WO2026039724A2 - Dispositifs et procédés de stabilisation de systèmes de gaine - Google Patents

Dispositifs et procédés de stabilisation de systèmes de gaine

Info

Publication number
WO2026039724A2
WO2026039724A2 PCT/US2025/042149 US2025042149W WO2026039724A2 WO 2026039724 A2 WO2026039724 A2 WO 2026039724A2 US 2025042149 W US2025042149 W US 2025042149W WO 2026039724 A2 WO2026039724 A2 WO 2026039724A2
Authority
WO
WIPO (PCT)
Prior art keywords
sheath
hub
distal end
introducer
proximal end
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/042149
Other languages
English (en)
Other versions
WO2026039724A3 (fr
Inventor
Allison Nicole RABIN
Jeffrey S. KASALKO
Ilan TAMIR
Ian Roy Johnson
Nasser William SALEH
Salomon Xavier VALENCIA
Sofia ROZENBERG
Mohamed Salah FAYAD
Noah Nuoxu YANG
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Edwards Lifesciences Corp
Original Assignee
Edwards Lifesciences Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Edwards Lifesciences Corp filed Critical Edwards Lifesciences Corp
Publication of WO2026039724A2 publication Critical patent/WO2026039724A2/fr
Publication of WO2026039724A3 publication Critical patent/WO2026039724A3/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0097—Catheters; Hollow probes characterised by the hub
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies

Definitions

  • the present application is directed to a sheaths and introducers for use with catheterbased technologies for repairing and/or replacing heart valves, as well as for delivering a medical device, such as a prosthetic, valve to a heart via the patient’ s vasculature.
  • Endovascular delivery catheter assemblies are used to implant prosthetic devices, such as prosthetic valves, at locations inside the body that are not readily accessible by surgery or where access without invasive surgery is desirable.
  • prosthetic devices such as prosthetic valves
  • aortic, mitral, tricuspid, and/or pulmonary prosthetic valves can be delivered to a treatment site using minimally invasive surgical techniques.
  • Percutaneous interventional medical procedures utilize the large blood vessels of the body to reach target destinations rather than surgically opening the target site.
  • diseases states that can be treated via percutaneous interventional methods, including (but not limited to) coronary blockages, valve replacements (TAVR) and brain aneurysms.
  • TAVR valve replacements
  • brain aneurysms These percutaneous interventional methods use wires, catheters, balloons, electrodes and other thin devices to travel down the length of the blood vessels from the access site to the target site.
  • the devices have a proximal end which the clinician controls outside of the body and a distal end inside the body.
  • Percutaneous interventional procedures offer several advantages over open surgical techniques. First, they require smaller incision sites which reduces scarring and bleeding as well as infection risk. Procedures are also less traumatic to the tissue, so recovery times are reduced. Finally, interventional procedures can usually be performed faster and with fewer clinicians, lowering costs. In some cases, the need for anesthesia is also eliminated, further speeding up the recovery process and reducing risk.
  • a single procedure typically uses several different guidewires, catheters, and balloons to achieve the desired effect.
  • each tool is inserted and then removed from the access site sequentially.
  • a guidewire is used to track the correct location within the body.
  • a balloon carried on a balloon catheter
  • an implant carried on yet another catheter
  • Introducer sheaths serve as conduits for the catheters. They are inserted into the access site to protect the vessel, which could otherwise be damaged by the introduction of multiple catheters with rough edges. Introducer sheaths also seal the blood vessel to reduce bleeding from the access site.
  • An introducer sheath generally has a proximally positioned housing and an elongated sleeve that is inserted into the vasculature.
  • the proximal housing contains one or more sealing valves that allow a delivery apparatus to be placed in fluid communication with the vasculature with minimal blood loss.
  • the femoral artery is often chosen as the vascular incision site.
  • the femoral approach involves creating an incision site in the femoral artery at the groin, then inserting the introducer sheath, and ultimately routing the delivery apparatus though the introducer sheath and to the target site. This method offers a straightforward path to major vessels, facilitating diagnostic imaging and interventions.
  • the femoral approach is often preferred over alternative approaches for several reasons, including the large diameter of the artery, the less tortuous path to the heart and major vessels, and the relative ease and safety of access. As such, introducer sheaths are often designed to be used with a femoral approach.
  • alternative vascular incision sites which are closer to the heart, may be used according to physician preference and/or when complications preclude the femoral approach. For example, navigating a catheter over the greater distance from the femoral incision site to the heart can be difficult with vascular complications like atherosclerosis, increased tortuosity, and reduced vascular elasticity. Introducer sheaths that are designed for the femoral approach are not well suited for use in these alternative vascular incision sites. Accordingly, there is a need for systems and methods that facilitate the use of introducer sheath systems at alternative vascular incision sites.
  • the present disclosure provides devices, systems, and methods for setting a length of the sheath so as to reduce a portion of the sheath that remains outside the patient’ s body during the procedure. This capacity is particularly advantageous where the distance between the incision site and the treatment site is less than an initial length of the sheath.
  • This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and/or described in conjunction with the figures, either in addition to or alternatively to the examples described hereafter.
  • An example method of setting a sheath length includes handling a sheath, where the sheath extends an initial sheath length between an initial distal end and an initial proximal end and defines a central lumen extending longitudinally therethrough. The initial proximal end of the sheath is coupled to an initial sheath hub.
  • the method also includes cutting the sheath at a cut location between the initial distal end and the initial proximal end so as to form a second proximal end and a second distal end on either side of the cut location, where cutting the sheath divides the sheath into a first section that has a first section length that extends from the initial distal end to the second proximal end and a second section that extends from the second distal end to the initial proximal end.
  • the method also includes coupling the second proximal end of the first section with a second sheath hub.
  • An example method of delivering a medical device through a sheath includes handling a radially expandable sheath that includes a continuous inner layer that extends an initial sheath length between an initial distal end and an initial proximal end and defines a central lumen extending longitudinally therethrough.
  • the initial proximal end of the sheath is coupled to an initial sheath hub and the inner layer has at least one folded portion extending along a length of the inner layer.
  • the method also includes cutting the sheath at a cut location between the initial distal end and the initial proximal end so as to form a second proximal end and a second distal end on either side of the cut location such that the sheath is divided into a first section that extends from the initial distal end to the second proximal end and a second section that extends from the second distal end to the initial proximal end.
  • the method also includes coupling the second proximal end of the first section with a second sheath hub, inserting the sheath into an incision site of a patient, and advancing a medical device through the central lumen of the sheath.
  • the method also includes advancing the medical device beyond a distal opening of the sheath to the treatment site.
  • An example sheath coupling system includes a sheath hub that includes a hub body that has a proximal end and a distal end and defines a lumen extending longitudinally therethrough.
  • the sheath coupling system also includes an initial hub cap coupled to the distal end of the sheath hub.
  • the initial hub cap has an initial hub cap proximal end and an initial hub cap distal end and defines an initial hub cap lumen extending longitudinally therethrough.
  • the sheath coupling system also includes a hub coupler coupled to the initial hub cap.
  • the hub coupler includes a hub coupler body that has a hub coupler proximal end and a hub coupler distal end and defines a hub coupler lumen extending longitudinally therethrough.
  • the sheath coupling system also includes a secondary hub cap disposed distal to the initial hub cap and coupled to the hub coupler.
  • the secondary hub cap has a secondary hub cap proximal end and a secondary hub cap distal end and defines a secondary hub cap lumen extending longitudinally therethrough.
  • the sheath coupling system also includes a sheath that includes a distal end and a proximal end and defines a central lumen extending longitudinally therethrough. The proximal end of the sheath is positioned between the distal end of the secondary hub cap and the distal end of the hub coupler such that coupling the secondary hub cap to the hub coupler fixes the sheath to the hub coupler and to the sheath hub.
  • Another example method of setting a sheath length includes handling a sheath, where the sheath extends an initial sheath length between an initial distal end and an initial proximal end and defines a central lumen extending therethrough.
  • the initial proximal end of the sheath is coupled to an initial sheath hub cap, and the initial sheath hub cap is coupled to a sheath hub.
  • the method also includes cutting the sheath at a first cut location between the initial distal end and the initial proximal end so as to form a second distal end and a second proximal end on either side of the cut location.
  • the method also includes cutting the sheath at a second cut location between the first cut location and the initial distal end so as to form a third distal end and a third proximal end on either side of the second cut location.
  • Cutting the sheath at the first cut location and second cut location divides the sheath into a first section that has a first section length extending from the initial distal end to the third proximal end, a second section that has a second section length extending from the third distal end to the second proximal end, and a third section that has a third section length extending from the second distal end to the initial proximal end.
  • the method also includes coupling a proximal end of a hub coupler to a distal end of the sheath hub; and coupling a proximal end of a secondary hub cap to a distal end of the hub coupler.
  • the sheath is positioned between a distal end of the secondary huh cap and the distal end of the hub coupler such that coupling the secondary sheath hub cap to the hub coupler fixes the sheath to the hub coupler and to the sheath hub.
  • Another example method of delivering a medical device includes handling a radially expandable sheath including a continuous inner layer extending an initial sheath length between an initial distal end and an initial proximal end and defining a central lumen extending longitudinally therethrough.
  • the initial proximal end of the sheath is coupled to an initial sheath hub cap and the initial sheath hub cap is coupled to a sheath hub.
  • the inner layer has at least one folded portion extending along a length of the inner layer.
  • the method also includes cutting the sheath at a first cut location between the initial distal end and the initial proximal end so as to form a second distal end and a second proximal end on either side of the cut location.
  • the method also includes cutting the sheath at a second cut location between the first cut location and the initial distal end so as to form a third distal end and a third proximal end on either side of the second cut location. Cutting the sheath at the first cut location and second cut location divides the sheath into a first section that has a first section length extending from the initial distal end to the third proximal end, a second section that has a second section length extending from the third distal end to the second proximal end, and a third section that has a third section length extending from the second distal end to the initial proximal end.
  • the method also includes coupling a proximal end of a hub coupler to a distal end of the hub.
  • the method also includes coupling a proximal end of a secondary hub cap to a distal end of the hub coupler, where the sheath is positioned between a distal end of the secondary hub cap and the distal end of the hub coupler such that coupling the secondary sheath hub cap to the hub coupler fixes the sheath to the hub coupler and to the sheath hub.
  • the method also includes inserting the sheath into an incision site of a patient.
  • the method also includes advancing a medical device through the central lumen of the sheath causing the sheath to locally expand from the unexpanded configuration to the expanded configuration at a location proximate the medical device in response to an outwardly directed radial force of the medical device exerted against the inner layer and locally contracting the sheath at least partially back to the unexpanded configuration as the medical device passes through the central lumen.
  • the method also includes advancing the medical device beyond a distal opening of the sheath to the treatment site.
  • An example introducer sheath system includes a sheath extending a length between a distal end and a proximal end and defining a central lumen extending longitudinally therethrough.
  • the introducer sheath system also includes a locking hub including a hub body having a proximal end and a distal end and defining a central lumen extending longitudinally between the proximal end and the distal end.
  • the introducer sheath system also includes an introducer coupled to the introducer locking hub and received within the sheath. The introducer extends beyond the distal end of the hub body and includes a proximal piece and a separate distal piece.
  • the proximal piece of the introducer is coupled to the introducer locking hub and defines a central lumen extending therethrough.
  • the distal end of the sheath is provided between the proximal piece and the distal piece of the introducer such that the distal end of the sheath does not extend radially beyond an outer diameter of the distal piece of the introducer.
  • Another example method of setting a sheath length includes handling a sheath, the sheath extending an initial sheath length between an initial distal end and an initial proximal end and defining a central lumen extending longitudinally therethrough.
  • the initial proximal end of the sheath is coupled to a sheath hub.
  • the method also includes cutting the sheath at a cut location between the initial distal end and the initial proximal end so as to form a second proximal end and a second distal end on either side of the cut location.
  • Cutting the sheath divides the sheath into a first section that has a first section length extending from the initial distal end to the second proximal end and a second section that has a second section length extending from the second distal end to the initial proximal end.
  • the method also includes inserting an introducer into the sheath hub and advancing the introducer through the central lumen of the sheath.
  • the method also includes moving a distal piece of the introducer from a first position adjacent the proximal piece to a second position axially spaced from the proximal piece.
  • the distal piece of the introducer includes a proximal end and a distal end.
  • the proximal end of the distal piece of the introducer includes a tapered region that tapers radially inward toward the distal end.
  • the method also includes and enclosing the initial distal end of the sheath within the tapered region of the distal piece of the introducer.
  • Another example method of delivering a medical device according to the present disclosure includes handling a sheath, the sheath extending an initial sheath length between an initial distal end and an initial proximal end and defining a central lumen extending longitudinally therethrough.
  • the initial proximal end of the sheath is coupled to a sheath hub.
  • the method also includes cutting the sheath at a cut location between the initial distal end and the initial proximal end so as to form a second proximal end and a second distal end on either side of the cut location. Cutting the sheath divides the sheath into a first section that has a first section length extending from the initial distal end to the second proximal end and a second section that has a second section length extending from the second distal end to the initial proximal end. The method also includes inserting an introducer into the sheath hub and advancing the introducer through the central lumen of the sheath.
  • the method also includes moving a distal piece of the introducer from a first position adjacent the proximal piece to a second position axially spaced from the proximal piece.
  • the distal piece of the introducer includes a proximal end and a distal end.
  • the proximal end of the distal piece of the introducer includes a tapered region that tapers radially inward toward the distal end.
  • the method also includes enclosing the second distal end of the sheath within the tapered region of the distal piece of the introducer.
  • the method also includes pushing the coupled sheath and introducer at least partially into the vasculature of a patient.
  • the method also includes withdrawing the introducer from the central lumen of the sheath.
  • the method also includes pushing a medical device through the central lumen of the sheath toward a treatment site.
  • the method also includes and delivering the medical device to the treatment site via the central lumen of the sheath.
  • the introducer sheath system includes a sheath coupled to and extending distally from the sheath hub.
  • the sheath extends a sheath length between a distal end and a proximal end and defines a central lumen extending longitudinally therethrough.
  • the introducer sheath system includes a suture hub at least partially surrounding the sheath.
  • the suture hub has a suture hub body with a proximal surface and a distal surface and defining a central lumen extending longitudinally therethrough.
  • the suture hub further includes one or more openings sized to house a suture for securing the suture hub to a patient.
  • the sheath is movable between a slidable configuration, in which the sheath is axially slidable within the central lumen of the suture hub, and a coupled configuration, in which the sheath is fixedly coupled to a locking mechanism on the suture hub to resist axial movement of the sheath.
  • An effective sheath length corresponding to a length of the sheath that is received within the patient is defined as the length of the sheath between distal surface of the suture hub and the distal end of the sheath.
  • Another example method of delivering a medical device through a sheath includes: inserting a sheath into a patient at an incision site; pushing a distal end of the sheath to a location within the patient's vasculature adjacent a treatment site; sliding a suture hub along an outer surface of the sheath; coupling the suture hub to a surface of the patient's skin adjacent to the incision site; and fixedly coupling the suture hub and the sheath so as to resist axial movement of the sheath.
  • An effective sheath length is defined as the length of the sheath that extends between a distal surface of the suture hub and the distal end of the sheath and corresponds to a length of the sheath that is received within a patient.
  • the method of delivering a medical device through a sheath also includes pushing a medical device through the sheath toward the treatment site.
  • FIG. 1 is an elevation view of an expandable sheath along with an endovascular delivery apparatus for implanting a medical device.
  • FIG. 2 is an elevation view of an expandable sheath including an introducer locking hub, a sheath locking sleeve, and an introducer.
  • FIG. 3 is an elevation view of the expandable sheath of FIG. 2 along with an endovascular delivery apparatus for implanting a medical device.
  • FIG. 4 is an elevation view of an expandable sheath a sheath hub, an introducer locking huh, and a sheath locking sleeve of FIG. 2.
  • FIG. 5A is a cross-sectional view of the sheath hub, introducer locking hub, and sheath locking sleeve of FIG. 2.
  • FIG. 5B is a cross-sectional view of the introducer cap, the sheath hub, the introducer locking hub, the sheath locking sleeve of FIG. 2.
  • FIG. 6 is a cross-sectional view of the introducer cap, sheath hub, introducer locking hub, and sheath locking sleeve of FIG. 2.
  • FIG. 7 is a distal end view of the sheath locking sleeve of FIG. 2 and the proximal fluid seal of FIGS 5A-B.
  • FIG. 8A is a first elevation view of the introducer locking hub of FIG. 2 coupled to an introducer.
  • FIG. 8B is a second (rotated) elevation view of the introducer locking hub of FIG. 2 coupled to the introducer.
  • FIG. 8C is a distal end view of the introducer locking hub of FIG. 2 coupled to the introducer.
  • FIG. 8D is a partial side view of the introducer locking hub of FIG. 2 coupled to the introducer.
  • FIG. 8E is a partial perspective view of the introducer locking hub of FIG. 2 coupled to the introducer.
  • FIG. 8F is a partial perspective view of the introducer locking hub of FIG. 2 coupled to the introducer.
  • FIG. 9A is a distal end view of the introducer locking hub of FIG. 2.
  • FIG. 9B is a first elevation view of the introducer locking hub of FIG. 2.
  • FIG. 9C is a proximal end view of the introducer locking hub of FIG. 2.
  • FIG. 9D is a first perspective view of the introducer locking hub of FIG. 2.
  • FIG. 9E is a second elevation view of the introducer locking hub of FIG. 2.
  • FIG. 9F is a second perspective view of the introducer locking hub of FIG. 2.
  • FIG. 10A is a distal end view of the sheath locking sleeve of FIG. 2.
  • FIG. 10B is a first elevation view of the sheath locking sleeve of FIG. 2.
  • FIG. 10C is a proximal end view of the sheath locking sleeve of FIG. 2.
  • FIG. 10D is a first perspective view of the sheath locking sleeve of FIG. 2.
  • FIG. 10E is a second elevation view of the sheath locking sleeve of FIG. 2.
  • FIG. 10F is a second perspective view of the sheath locking sleeve of FIG. 2.
  • FIG. 11 is a side elevation cross-sectional view of a portion of the expandable sheath of FIGS. 1 and 2.
  • FIG. 12 is a magnified view of a portion of the expandable sheath of FIGS. 1 and 2.
  • FIG. 13A is a magnified view of a portion of the expandable sheath of FIGS. 1 and 2 with the outer layer removed for purposes of illustration.
  • FIG. 13B is a magnified view of a portion of the braided layer of the sheath of FIGS. 1 and 2.
  • FIG. 14 is a magnified view of a portion of the expandable sheath of FIGS. 1 and 2 illustrating expansion of the sheath as a medical device is advanced through the sheath.
  • FIG. 15 is a side view of the expandable sheath of FIGS. 1 and 2.
  • FIG. 16 is a magnified cross-sectional section view of the sheath of FIG. 15 along section line 16-16.
  • FIG. 17 is cross-sectional view of the unexpanded sheath of FIG. 16 along section line 17-17.
  • FIG. 18 is cross-sectional view of the unexpanded sheath of FIG. 15 along section line 18-18.
  • FIG. 19 is cross-sectional view of the unexpanded sheath of FIG. 15 along section line 19-19.
  • FIG. 20 is cross-sectional view of the expanded sheath of FIG. 15 along section line 19-19.
  • FIG. 21 is a side view of the expandable sheath of FIGS. 1 and 2.
  • FIG. 22 is a cross-sectional view of the unexpanded sheath of FIG. 21 along section line 22-22.
  • FIG. 23 is a cross-sectional view of the expanded sheath of FIG. 21 along section line 22-22.
  • FIG. 24 shows various percutaneous vascular access approaches.
  • FIG. 25 shows side views of an introducer sheath system according to another example, where a length of the sheath is adjusted.
  • FIG. 26 is a perspective view of a sheath coupling system according to one example, the introducer sheath system including a hub coupler for coupling an initial hub cap of the introducer sheath system with a secondary hub cap of the introducer sheath, thereby coupling the sheath with the sheath hub.
  • FIG. 27 is an enlarged cross-sectional side view of the sheath coupling system of FIG. 26.
  • FIG. 28 is a perspective view of the hub coupler of FIG. 26.
  • FIG. 29A shows side views of an introducer sheath system according to another example, where a length of the sheath is adjusted.
  • FIG. 29B shows side views of an introducer sheath system of FIG. 29A, including a hub coupler for coupling the sheath to a sheath hub.
  • FIG. 30 shows side views of an introducer sheath system according to another example, where a length of the sheath is adjusted and an introducer is inserted into a sheath hub.
  • FIG. 31 is a cross-sectional side view of the introducer of FIG. 30.
  • FIG. 32 is a side view of the introducer sheath system of FIG. 30, where the introducer is inserted into the sheath after the length of the sheath has been adjusted.
  • FIG. 33 is a side view of an introducer sheath system according to another example, the introducer sheath system including a suture hub for coupling a sheath to a patient.
  • FIG. 34 is a side view of the example suture hub of FIG. 33.
  • FIG. 35 is a side view of an example suture hub according to another example.
  • FIG. 36 is a side view of a loader assembly used for loading a balloon catheter and medical device into the introducer sheath system of FIG. 33.
  • FIGS. 37 and 38 are side views illustrating the insertion of a delivery system into a loader assembly of FIG. 36.
  • the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another.
  • the disclosed methods, systems, and apparatus are not limited to any specific aspect, feature, or combination thereof, nor do the disclosed methods, systems, and apparatus require that any one or more specific advantages be present or problems be solved.
  • proximal and distal refer to regions of a sheath, catheter, or delivery assembly. “Proximal” means that region closest to handle of the device, while “distal” means that region farthest away from the handle of the device.
  • “Axially” or “axial” as used herein refers to a direction along the longitudinal axis of the sheath.
  • the word “comprise” and variations of the word, such as “comprising” and “comprises,” means “including but not limited to,” and is not intended to exclude, for example, other additives, components, integers or steps.
  • “Exemplary” means “an example of’ and is not intended to convey an indication of a preferred or ideal aspect. “Such as” is not used in a restrictive sense, but for explanatory purposes.
  • Disclosed examples of an expandable sheath can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the device passes through.
  • Disclosed examples of the introducer sheath prevent the introducer/dilator from separating from the sheath during insertion by locking of the proximal hub of the introducer/dilator to the proximal hub of the sheath. Fixing the introducer/dilator and the sheath prevents the introducer/dilator from moving backward during insertion, thereby maintaining a snug fit and smooth transition between the introducer/dilator and the distal end of the sheath.
  • present examples can reduce the length of time a procedure takes, as well as reduce the risk of a longitudinal or radial vessel tear, or plaque dislodgement because only one sheath is required, rather than several different sizes of sheaths.
  • present expandable sheath can avoid the need for multiple insertions for the dilation of the vessel.
  • elongate introducer sheaths that are particularly suitable for delivery of implants in the form of implantable heart valves, such as balloon-expandable implantable heart valves.
  • Implantable heart valves such as balloon-expandable implantable heart valves.
  • Balloon-expandable implantable heart valves are well-known and will not be described in detail here.
  • An example of such an implantable heart valve is described in U.S. Patent No. 5,411,552, and also in U.S. Patent No. 9,393,110, both of which are hereby incorporated by reference.
  • the expandable introducer sheaths disclosed herein may also be used to deliver other types of implantable medical device, such as self-expanding and mechanically expanding implantable heart valves, stents or filters.
  • the introducer sheath system can be useful for other types of minimally invasive surgery, such as any surgery requiring introduction of an apparatus into a subject’s vessel.
  • the introducer sheath system can be used to introduce other types of delivery apparatus for placing various types of intraluminal devices (for example, stents, stented grafts, balloon catheters for angioplasty procedures, etc.) into many types of vascular and non-vascular body lumens (for example, veins, arteries, esophagus, ducts of the biliary tree, intestine, urethra, fallopian tube, other endocrine or exocrine ducts, etc.).
  • intraluminal devices for example, stents, stented grafts, balloon catheters for angioplasty procedures, etc.
  • vascular and non-vascular body lumens for example, veins, arteries, esophagus, ducts of the biliary tree, intestine, urethra, fall
  • Example expandable introducer sheaths are disclosed, for example, in U.S. Patent No. 8,690,936, entitled “Expandable Sheath for Introducing an Endovascular Delivery Device into a Body,” U.S. Patent No. 8,790,387, entitled “Expandable Sheath for Introducing an Endovascular Delivery Device into a Body,” U.S. Patent No. 10,639,152, entitled “Expandable Sheath and Methods of Using the Same,” U.S. Patent No.
  • PCT/US2021/031275 entitled “Expandable sheath for introducing an endovascular delivery device into a body”
  • Application No. PCT/US2021/058247 entitled “Self-Expanding, Two Component Sheath”
  • Application No. PCT/US2022/012785 entitled “Expandable Sheath”
  • U.S. Patent No. 11,051,939 entitled “Active Introducer Sheath System”
  • Application No. PCT/US2022/012684 entitled “Introducer with Sheath Tip Expander”
  • PCT/US2021/025038 entitled “Low temperature hydrophilic adhesive for use in expandable sheath for introducing an endovascular delivery device into a body
  • Application No. PCT/US2021/050006 entitled “Expandable Sheath Including Reversable Bayonet Locking Hub”
  • U.S. Provisional Application No. 63/280,251 entitled “Expandable Sheath Gasket to Provide Hemostasis”
  • U.S. Provisional Application No. 63/530,144 entitled “Introducer/Dilator with Folded Balloon”
  • U.S. Provisional Application No. 63/502,907 entitled “Lead Screw Driven Sheath Dilator,” the disclosures of which are herein incorporated by reference.
  • FIG. 1 illustrates an exemplary sheath 8 in use with a representative delivery apparatus 10, for delivering a medical device 12, or other type of implantable (for example, tissue heart valve), to a patient.
  • the delivery apparatus 10 can include a steerable guide catheter 14 (also referred to as a flex catheter) and a balloon catheter 16 extending through the guide catheter 14, and a nose catheter 15 extending through the balloon catheter 16.
  • the guide catheter 14, balloon catheter 16, and nose catheter 15 in the illustrated example are adapted to slide longitudinally relative to each other to facilitate delivery and positioning of the medical device 12 at an implantation site in a patient’s body as described in detail herein.
  • the sheath 8 can be used with any type of elongated delivery apparatus used for implanting balloon-expandable prosthetic valves, self-expanding prosthetic valves, and other prosthetic devices.
  • the sheath 8 comprises an elongate expandable tube that, in use, is inserted into a vessel (for example, transfemoral vessel, femoral artery, iliac artery) by passing through the skin of patient, such that the distal end of the sheath 8 is inserted into the vessel.
  • Sheath 8 includes a hemostasis valve and/or sealing features at the proximal end of the sheath, for example, in the sheath hub 20, that provide hemostasis and prevents blood leakage from the patient through the sheath 8.
  • the sheath 8, including an introducer 6 (also referred to herein as a dilator), is advanced into the patient’s vasculature. Once positioned the introducer 6 is removed and the delivery apparatus 10 is inserted into/through the sheath 8, and the prosthetic device (medical device 12) then be delivered and implanted within patient.
  • the introducer device/sheath assembly includes a sheath hub 20 at a proximal end of the device and an expandable sheath 8 extending distally from the sheath hub 20.
  • the sheath 8 is coupled to the sheath hub 20 which in turn is removably coupled to a sheath locking system 18.
  • the sheath locking system 18 allows the introducer 6, or other device desired to be removably couped (axially and rotatably) to the sheath 8.
  • the sheath hub 20 can function as a handle for the device.
  • Sheath hub 20 also provides a housing for necessary seal assemblies and an access point for a secondary lumen (for example, fluid lumen) in fluid communication with the central lumen of the sheath hub 20.
  • the seal assembly 24, as described herein and as shown in FIGS. 5 A and 5B, is included in the sheath hub 20.
  • the seal assembly 24 includes a proximal seal 24a, an intermediate seal 24b, and a distal seal 24c. When assembled, the introducer 6 passes through the seal assembly and extends distal of the sheath 8.
  • the proximal seal 24a, the intermediate seal 24b, and the distal seal 24c are each formed to prevent unwanted fluid from advancing in the proximal direction through the sheath hub 20 and proximal of the seal assembly 24. They are each openable and closable to provide pressure variation to affect the desired fluid flow from a physician or technician.
  • the distal end of the sheath hub 20 includes threads 21 for coupling to a threaded sheath hub cap 22.
  • the sheath 8 is provided between the sheath hub 20 and the sheath hub cap 22 such that coupling the sheath hub cap 22 to the sheath hub 20 fixes the sheath 8 to the sheath hub 20.
  • the sheath hub cap 22 is a cylindrical cap having a cap body having a proximal end and a distal end and defining a central lumen extending longitudinally between the proximal end and the distal end.
  • the sheath hub cap 22 has a larger diameter at its proximal end than at its distal end.
  • the sheath hub 20 further has receiving slots 48 for coupling the sheath locking system 18, particularly the locking sleeve 28, to the sheath hub 20.
  • the receiving slots 48 are openings which extend around a portion of the diameter of the sheath hub 20 and are sized and configured to accept the interference diameters 66 of the locking sleeve 28. Coupling between the receiving slots 48 and the interference diameters 66 axially and rotationally fixes the locking sleeve 28 and the sheath hub 20 relative to each other.
  • FIG. 2 illustrates the sheath 8 of FIG. 1 including a sheath locking system 18 which prevents axial and rotational translation of the introducer 6 with respect to the sheath 8.
  • Example locking systems are disclosed in PCT/US2021/050006, entitled “Expandable Sheath Including Reverse Bayonet Locking Hub,” the disclosure of which is incorporated herein by reference. It is contemplated that the locking system disclosed herein can also be used to couple the sheath 8/sheath hub 20 with other delivery apparatus components, catheters, dilators, etc. including the same mating features.
  • the sheath locking system 18 keeps the introducer 6 fixed with respect to the sheath 8 during insertion without requiring a physician or technician to hold the introducer 6 and the sheath 8 in place at the distal end.
  • the sheath locking system 18 includes a locking sleeve 28 and an introducer locking hub 30 (including corresponding introducer 6).
  • the locking sleeve 28 is coupled to the sheath 8 via the sheath hub 20.
  • the locking sleeve 28 engages the introducer locking hub 30 and is moveable between a locked and unlocked position, thereby fixing the position of the introducer 6 and the sheath 8 and preventing movement therebetween, particularly during insertion into the patient.
  • the sheath locking system 18 keeps the introducer 6 from separating from the sheath 8 and prevents gaps from forming that can cause patient abrasions and unintended fluid flow between the introducer 6 and the sheath 8 during insertion.
  • the locking sleeve 28 includes a guide 31 that engages a locking channel 38 provided on the introducer locking hub 30.
  • the guide 31 moves within the locking channel 38 between an unlocked position, where the locking sleeve 28 is rotationally and axially movable with respect to the introducer locking hub 30, and a locked position (FIG. 2), where the locking sleeve 28 is axially fixed with respect to the introducer locking hub 30.
  • the locking sleeve 28 is illustrated, for example, in FIGS. 10A-10F.
  • the locking sleeve 28 includes an elongated sleeve body 29 with a central lumen 56 extending longitudinally between the proximal end 58 and distal end 60 of the sleeve body 29.
  • the central lumen 56 defines a generally cylindrical inner surface 62 of the sheath locking sleeve 28.
  • the central lumen 56 has a diameter of at least 0.3 inches. In some examples, the diameter ranges between 0.3 inches and 0.6 inches. Preferably, the diameter is about 0.40 inches.
  • the distal end 60 of the sleeve body 29 also has a frustoconical outer surface 64 that tapers about the distal end 60 to help with positioning the locking sleeve 28 within the sheath hub 20 and abutting the seal assembly 24 (FIGS. 5B and 5B).
  • the locking sleeve 28 also has a plurality of interference diameters 66 that extend radially from the outer surface of the sleeve body 29 around (all or a portion of) the circumference of the locking sleeve 28. As illustrated in FIGS.
  • the distal interference diameters 66 are sized and configured to engage corresponding recesses and/or slots 48 provided in the sheath hub 20 for securing the locking sleeve 28 to the sheath hub 20, and the distal interference diameter 66 seat against the proximal end of the sheath hub 20.
  • the locking sleeve 28 includes a guide 31 projecting from the outer surface 68 of the locking sleeve 28.
  • the guide 31 engages a corresponding shaped locking channel 38 in the introducer locking hub 30.
  • the guide 31 extends radially from the outer surface 68 and at least partially around the circumference of the outer surface 68.
  • the top surface of the guide 31 does not extend beyond the outer surface of the introducer locking hub 30 when the locking sleeve 28 and the introducer locking hub 30 are coupled.
  • the height of the guide 31 corresponds to the wall thickness of the introducer locking hub 30 proximate the guide when the locking sleeve 28 and the introducer locking hub 30 are coupled.
  • the top surface of the guide 31 is recessed with respect to the outer surface of the introducer locking hub 30. That is, the height of the guide 31 is less than the wall thickness of the introducer locking hub 30. In some examples, the height of the guide 31 is greater than a wall thickness of the introducer locking hub 30 such that the top surface of the guide 31 extends beyond the outer surface of the introducer locking hub 30 when the locking sleeve 28 and the introducer locking hub 30 are coupled. In some examples, the height/axial length of the guide 31 is between about 0.050 inches and about 0.10 inches. In some examples that height/axial length of the guide 31 is about 0.075 inches. [00101] As illustrated in FIGS. 10D-10F, the guide 31 is a cylindrically shaped projection.
  • the guide 31 may have any other regular or irregular shape that would facilitate movement of the guide 31 within the locking channel 38 of the introducer locking hub 30.
  • the guide 31 may have an elongated hexagon shape.
  • the guide 31 can have a diameter/width ranging from about 0.05 inches to about 0.20 inches.
  • Preferably the guide 31 has a diameter/width of about 0.100 inches.
  • the locking sleeve 28 can comprise polycarbonate, but in some examples, the locking sleeve 28 can comprise rigid plastic, or any other material suitable for providing a strong locking connector for an introducer 6 (metal, composite, etc.).
  • FIGS. 2-6 illustrate the introducer locking hub 30 coupled to the locking sleeve 28.
  • FIGS. 8A-8F show the introducer locking hub 30 coupled to the introducer 6.
  • FIGS. 9A-9F provide multiple view of the introducer locking hub 30.
  • the introducer 6 is fixedly coupled to the introducer locking hub 30.
  • the introducer locking hub 30 couples with the locking sleeve 28 to fix the position the introducer 6 (axially and rotationally) with respect to the locking sleeve 28/sheath 8.
  • Each of the introducer 6 and introducer locking hub 30 are described in more detail as follows.
  • FIGS. 8A-8F illustrate the introducer locking hub 30 with the introducer 6 coupled thereto.
  • Example introducer sheaths are described, for example in U.S. Patent Nos. 8,690,936 and 8,790,387, the disclosures of which are incorporated herein by reference.
  • the introducer 6 is coupled to the introducer locking hub 30 and extends beyond the distal end of the introducer locking hub 30 body and into the sheath 8.
  • the introducer 6 When coupled to the sheath hub 20, the introducer 6 extends through the central lumen 56 of the locking sleeve 28, the sheath hub 20 and the central lumen of the sheath 8.
  • the sheath 8 generally comprises a radially expandable tubular structure. Passage of the introducer 6 through the sheath 8 and into a patient’s vasculature causes the blood vessel to radially expand to about the diameter of the sheath 8. That is, the diameter of the central lumen of the sheath 8 is generally abuts the outer diameter of the introducer 6 such that the introducer 6 provides a mechanism to expand a patient’s vessel to accept the sheath.
  • the introducer 6 is formed as an elongate body with a central lumen extending therethrough. As shown in FIGS. 5A and 5B, the central lumen of the introducer is aligned with the central lumens of the introducer locking hub 30, the sheath hub 20 and the sheath 8. The introducer 6 is received within a recessed opening 39 provided on an interior surface of the introducer locking hub 30, the recessed opening 39 axially aligned with the central lumen 45 of the introducer locking hub 30. The introducer 6 is coupled to the introducer locking hub 30 at the recessed opening 39. In an example system, the introducer 6 has a diameter corresponding to, or less than, the diameter of the recessed opening 39.
  • the introducer 6 is fixedly coupled to the introducer locking hub 30 at the recessed opening 39.
  • the introducer 6 is coupled to the recessed opening 39 of the introducer locking hub 30 by at least one of a press fit, an interference fit, a snap fit, a mechanical fastener, a chemical fastener (for example, an adhesive), a weld, a thermal process, and/or any other suitable coupling process known in the art.
  • the introducer 6 has a central lumen that aligns with the central lumen 45 of the introducer locking hub 30. This joined lumen allows for the passage of surgical equipment and/or medical devices to the treatment site (for example, a guide wire).
  • the central lumen of the introducer 6 has a diameter corresponding to at least a portion of the diameter of the central lumen 45 of the introducer locking hub 30. In general, the corresponding diameter portion is adjacent the distal end of the central lumen 45. In some examples, the diameter of the central lumen 45 at the distal end of the introducer locking hub 30 is slightly larger than the diameter of the central lumen passing through the introducer 6.
  • the central lumen 45 can also define a decreasing tapered portion 41 between the proximal end and the distal end of the introducer locking hub 30 (see FIG. 6).
  • the corresponding diameter portion and decreasing tapered portion 41 allows for smooth transition and delivery of surgical equipment and/or medical device through the introducer locking hub 30 and into the central lumen of the introducer 6.
  • the introducer locking hub 30 includes a introducer locking hub body 32 having a proximal end 70 and a distal end 72 and defining a central lumen 45 extending therethrough.
  • the introducer locking hub body 32 has a first (middle) portion 33, a second (distal) portion 35 which extends distally from the first portion 33 and a third (proximal) portion 37 which extends proximally from the first portion 33.
  • the first portion 33 includes the cylindrically-shaped recessed opening 39 for receiving and retaining the introducer 6 and an outer surface 43.
  • the recessed opening 39 has a diameter ranging between 0.15 inches and about 0.25 inches.
  • the recessed opening 39 has a diameter ranging between 0. 17 inches and about 0.20 inches.
  • the recessed opening has a diameter of about 0.194 inches.
  • the third (proximal) portion 37 of the introducer locking hub 30 includes the decreasing tapered portion 41 of the central lumen 45.
  • the decreasing taper portion 41 defining a frustoconical shape with decreasing taper/diameter from the proximal to the distal end of the sheath. It is contemplated that the tapered portion 41 has a minimum diameter of about 0.007 inches and a maximum diameter of about 0.194 inches.
  • the central lumen 56 of the locking sleeve 28 when coupled, is aligned with the central lumen 45 of the introducer locking hub 30. In some examples, the central lumen 56 of the locking sleeve 28 is coaxial with the central lumen 45 of the introducer locking hub 30.
  • the proximal end of the locking sleeve 28 is received within the central lumen 45 of the introducer locking hub 30.
  • the proximal end surface of the locking sleeve 28 is adjacent a shoulder 50 provided on an inner surface of the central lumen 45 of the introducer locking hub 30.
  • the central lumen 45 of the introducer locking hub 30 includes a first portion 52 having a first diameter adjacent the proximal end of the introducer locking hub 30, and a second portion 54 having a second, larger, diameter adjacent the distal end of the introducer locking hub 30.
  • the recessed opening 39 can be considered either a component of the first portion 52 of the central lumen 45, or a separate component of the central lumen 45 located between the first (proximal) portion 52 and the second (distal) portion 54.
  • the locking sleeve 28 and introducer locking hub 30 are coupled, at least a portion of the sleeve body 29 of the locking sleeve 28 is received within the second portion 54 (larger portion) of the central lumen 45 of the introducer locking hub 30.
  • the central lumen 56 of the locking sleeve 28 is aligned with the central lumen 45 of the introducer locking hub 30 such that they are co-axial and form a smooth inner surface along the combined central lumens of the introducer locking hub 30 and the locking sleeve 28.
  • the locking sleeve 28 couples to the introducer locking hub 30 via engagement between the guide 31 on the locking sleeve 28 and the locking channel 38 provided in the introducer locking hub 30.
  • the introducer locking hub 30 includes two locking channels 38.
  • the introducer locking hub 30 can include one locking channel 38 or more than two locking channels 38.
  • the locking channel 38 can be is formed a recess or groove in a surface of the introducer locking hub 30, as a slotted opening, a clip, or as any other feature capable of receiving and securing the guide 31 projecting from the outer surface of the locking sleeve 28 with the introducer locking hub 30.
  • the locking channels 38 provide an interface to secure the locking sleeve 28 to the introducer locking hub 30 and ensure a fixed axial position between the introducer 6 and the sheath 8.
  • the locking channel 38 is formed on the distal end of the introducer locking hub 30.
  • the locking channel 38 includes an opening on the distal end surface that leads to an angled guide portion 40 that transitions to a locking portion 42.
  • the guide portion 40 is configured to direct the guide 31 of the locking sleeve 28 in an axial and circumferential direction along the side wall of the guide portion 40 towards the locking portion 42 upon rotation of the introducer locking hub 30 and/or the locking sleeve 28.
  • the locking portion 42 is configured to securely engage the guide 31, fixing the axial position of the introducer locking hub 30 with respect to the locking sleeve 28. As illustrated in FIG.
  • the guide portion 40 of the locking channel 38 extends from the distal end of the introducer locking hub 30 axially towards the proximal end of the introducer locking hub 30 and circumferentially around the introducer locking hub 30.
  • the guide portion 40 of the locking channel 38 can be described as extending helically around/along a length of the introducer locking hub 30 or on an angle from the distal end of the introducer locking hub 30.
  • the locking portion 42 of the locking channel 38 extends at an angle from the end of the guide portion 40.
  • the angle between the centerline of the guide portion 40 and the centerline of the locking portion 42 is greater than 90-degrees.
  • the angle between the centerline of the guide portion 40 and the centerline of the locking portion 42 is about 120-degrees.
  • the locking portion 42 extends around a portion of the circumference of the introducer locking hub 30.
  • the locking portion 42 can extend parallel to the distal end of the introducer locking hub 30.
  • the length of the guide portion 40 (measured along its centerline) is greater than a length of the locking portion 42 (measured along its centerline). In some examples, the length of the guide portion 40 equals or is less than a length of the locking portion 42.
  • the locking portion 42 can include a catch 44 for securing the guide 31 within the locking portion 42 of the locking channel 38 and forming a partial barrier for the guide 31 within the locking portion 42.
  • the catch 44 includes a projection that extends from a side wall 74 of the locking portion 42 and releasably secures the guide 31 within the locking channel 38.
  • the catch 44 extends from the side wall 42a of the locking portion 42 in a proximal direction towards the center line of the locking portion 42 and has a height sufficient to retain the guide 31 between the catch 44 and the end of the locking portion 42.
  • the distal end surface 72 of the introducer locking hub 30 can include features for biasing the guide 31 towards and into the locking channel 38.
  • the distal end of the introducer locking hub 30 can include a tapered surface angled toward an opening of the locking channel 38.
  • the distal end 72 of the introducer locking hub 30 includes a first tapered surface 76 (angled towards a leading edge of the opening of the locking channel 38 and a second tapered surface 78 angled towards the trailing edge of the opening of the locking channel 38.
  • engagement between the guide 31 and the guide portion 40 of the locking channel 38 is configured to bias the locking sleeve 28 in a proximal axial direction toward the proximal end 70 of the introducer locking hub 30 (towards a locked position) when the locking sleeve 28 is rotated in a first axial direction. In this direction the guide 31 advances toward the locking portion 42 of the locking channel 38 into the locked position.
  • engagement between the guide 31 and the locking portion 42 of the locking channel 38 is configured to bias the locking sleeve 28 in a distal axial direction toward the distal end of the introducer locking hub 30 (towards an unlocked position) when the locking sleeve 28 is rotated in a second (opposite) axial direction.
  • the guide 31 and the locking portion 42 of the locking channel 38 are configured to bias the locking sleeve 28 in a distal axial direction toward the distal end of the introducer locking hub 30 (towards an unlocked position) when the locking sleeve 28 is rotated in a second (opposite) axial direction. In the second direction, the guide
  • the introducer locking hub body 32 includes gripping features and/or surfaces for a physician or technician to use when manipulating the introducer locking hub 30.
  • the introducer locking hub body 32 can include a two recessed gripping surfaces 34 on opposite sides of the longitudinal axis of the introducer locking hub 30.
  • the gripping surfaces 34 define a dog-bone/barbell shape to the hub body 32, i.e., a shape having a smaller diameter/width center portion and larger diameter/width end portions.
  • the gripping surfaces 34 are provided along at least 40% of the length of the introducer locking hub body 32. In some examples, the gripping surfaces 34 are provided along at least 50% of the length of the introducer locking hub body 32.
  • the introducer locking hub 30 can comprise polycarbonate, but in some examples the introducer locking hub 30 can comprise rigid plastic, or any other material suitable for providing a locking mechanism for an introducer 6 (metal, composite, etc.).
  • the introducer device/sheath assembly includes an expandable sheath 8 extending distally from the sheath hub 20.
  • the expandable sheath 8 has a central lumen to guide passage of the delivery apparatus 10 for the medical device 12 (for example, an implant such as a prosthetic heart valve).
  • the introducer device/sheath assembly need not include the sheath hub 20.
  • the sheath 8 can be an integral part of a component of the sheath assembly, such as the guide catheter.
  • the expandable sheath 8 can comprise a plurality of coaxial layers extending along at least a portion of the length of the sheath 8.
  • the structure of the coaxial layers is described in more detail herein with respect to FIGS. 11-23.
  • Example expandable sheaths including coaxial layers are described, for example, in U.S. Patent Application No. 16/378,417, entitled “Expandable Sheath,” and U.S. Patent Application No. 17/716,882, entitled “Expandable Sheath,” the disclosures of which are herein incorporated by reference.
  • the expandable sheath 8 can include a number of layers including an inner layer 102 (also referred to as an inner liner), a second layer 104 disposed around and radially outward of the inner layer 102, a third layer 106 disposed around and radially outward of the second layer 104, and a fourth outer layer 108 (also referred to as an outer liner) disposed around and radially outward of the third layer 106.
  • an inner layer 102 also referred to as an inner liner
  • second layer 104 disposed around and radially outward of the inner layer 102
  • a third layer 106 disposed around and radially outward of the second layer 104
  • a fourth outer layer 108 also referred to as an outer liner
  • the inner layer 102 can define the lumen 112 of the sheath extending along a central axis 114 through which the delivery apparatus travels into the patient’s vessel in order to deliver, remove, repair, and/or replace a prosthetic device, moving in a direction along the longitudinal axis of the sheath 8.
  • various layers of the sheath for example, the inner layer 102 and/or the outer layer 108, can form longitudinally-extending folds or creases such that the surface of the sheath comprises a plurality of folds or ridges 126.
  • the ridges 126 can be circumferentially spaced apart from each other by longitudinally-extending valleys 128. When the sheath expands beyond its natural diameter DI, the ridges 126 and the valleys 128 can level out or be taken up as the surface radially expands and the circumference increases, as further described herein. When the sheath 8 collapses back to its natural diameter, the ridges 126 and valleys 128 can reform.
  • the inner layer 102 and/or the outer layer 108 can comprise a relatively thin layer of polymeric material.
  • the thickness of the inner layer 102 can be from 0.01 mm to 0.5 mm, 0.02 mm to 0.4 mm, or 0.03 mm to 0.25 mm.
  • the thickness of the outer layer 108 can be from 0.01 mm to 0.5 mm, 0.02 mm to 0.4 mm, or 0.03 mm to 0.25 mm.
  • the inner layer 102 and/or the outer layer 108 can comprise a lubricious, low-friction, and/or relatively non-elastic material.
  • the inner layer 102 and/or the outer layer 108 can comprise a polymeric material having a modulus of elasticity of 400 Mpa or greater.
  • Exemplary materials can include ultra-high-molecular- weight polyethylene (UHMWPE) (for example, Dyneema®), high-molecular-weight polyethylene (HMWPE), or polyether ether ketone (PEEK).
  • UHMWPE ultra-high-molecular- weight polyethylene
  • HMWPE high-molecular-weight polyethylene
  • PEEK polyether ether ketone
  • suitable materials for the inner and outer layers can include polyimide, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), ethylene tetrafluoroethylene (ETFE), nylon, polyethylene, polyamide, polyether block amide (for example, Pebax), and/or combinations of any of the above.
  • the sheath 8 can include a lubricious liner on the inner surface of the inner layer 102.
  • suitable lubricious liners include materials that can further reduce the coefficient of friction of the inner layer 102, such as PTFE, polyethylene, polyvinylidene fluoride, and combinations thereof.
  • Suitable materials for a lubricious liner also include other materials desirably having a coefficient of friction of 0.1 or less.
  • the sheath 8 can include an exterior hydrophilic coating on the outer surface of the outer layer 108.
  • a hydrophilic coating can facilitate insertion of the sheath 8 into a patient’s vessel, reducing potential damage.
  • suitable hydrophilic coatings include the HarmonyTM Advanced Lubricity Coatings and other Advanced Hydrophilic Coatings available from SurModics, Inc., Eden Prairie, MN. DSM medical coatings (available from Koninklijke DSM NV, Heerlen, the Netherlands), as well as other hydrophilic coatings (for example, PTFE, polyethylene, polyvinylidene fluoride), are also suitable for use with the sheath 8.
  • hydrophilic coatings may also be included on the inner surface of the inner layer 102 to reduce friction between the sheath and the delivery apparatus, thereby facilitating use and improving safety.
  • a hydrophobic coating such as Perylene, may be used on the outer surface of the outer layer 108 or the inner surface of the inner layer 102 in order to reduce friction.
  • the second layer 104 can be a braided layer.
  • FIGS. 13A and 13B illustrate the sheath 8 with the outer layer 108 removed to expose the elastic third layer 106.
  • the braided second layer 104 can comprise a plurality of members or filaments 110 (for example, metallic or synthetic wires or fibers) braided together.
  • the braided second layer 104 can have any desired number of filaments 110, which can be oriented and braided together along any suitable number of axes. For example, with reference to FIG.
  • the filaments 110 can include a first set of filaments 110A oriented parallel to a first axis A, and a second set of filaments HOB oriented parallel to a second axis B.
  • the filaments 110A and 110B can be braided together in a biaxial braid such that filaments 110A oriented along axis A form an angle 0 with the filaments HOB oriented along axis B.
  • the angle 0 can be from 5° to 70°, 10° to 60°, 10° to 50°, or 10° to 45°. In the illustrated example, the angle 0 is 45°.
  • the filaments 110 can also be oriented along three axes and braided in a triaxial braid, or oriented along any number of axes and braided in any suitable braid pattern.
  • the braided second layer 104 can extend along substantially the entire length L of the sheath 8, or alternatively, can extend only along a portion of the length of the sheath.
  • the filaments 110 can be wires made from metal (for example, Nitinol, stainless steel, etc.), or any of various polymers or polymer composite materials, such as carbon fiber.
  • the filaments 110 can be round, and can have a diameter of from 0.01 mm to 0.5 mm, 0.03 mm to 0.4 mm, or 0.05 mm to 0.25 mm.
  • the filaments 110 can have a flat cross-section with dimensions of 0.01 mm x 0.01 mm to 0.5 mm x 0.5 mm, or 0.05 mm x 0.05 mm to 0.25 mm x 0.25 mm. In one aspect, filaments 110 having a flat cross-section can have dimensions of 0.1 mm x 0.2 mm. However, other geometries and sizes are also suitable for certain aspects. If braided wire is used, the braid density can be varied. Some examples have a braid density of from ten picks per inch to eighty picks per inch, and can include eight wires, sixteen wires, or up to fifty-two wires in various braid patterns.
  • the second layer 104 can be laser cut from a tube, or laser-cut, stamped, punched, etc., from sheet stock and rolled into a tubular configuration. The second layer 104 can also be woven or knitted, as desired.
  • the third layer 106 can be a resilient, elastic layer (also referred to as an elastic material layer).
  • the elastic third layer 106 can be configured to apply radially inward force to the underlying inner layer 102 and second layer 104 in a radial direction (for example, toward the central axis 114 of the sheath) when the sheath expands beyond its natural diameter by passage of the delivery apparatus through the sheath.
  • the elastic third layer 106 can be configured to apply encircling/radially inward pressure to the layers of the sheath beneath the elastic third layer 106 to counteract expansion of the sheath.
  • the elastic third layer 106 can comprise one or more members configured as strands, ribbons, or elastic bands 116 helically wrapped around the braided second layer 104.
  • the elastic third layer 106 comprises two elastic bands 116A and 116B wrapped around the braided second layer 104 with opposite helicity, although the elastic layer may comprise any number of bands depending upon the desired characteristics.
  • the elastic bands 116A and 116B can be made from, for example, any of a variety of natural or synthetic elastomers, including silicone rubber, natural rubber, any of various thermoplastic elastomers, polyurethanes such as polyurethane siloxane copolymers, urethane, plasticized polyvinyl chloride (PVC), styrenic block copolymers, polyolefin elastomers, etc.
  • the elastic layer can comprise an elastomeric material having a modulus of elasticity of 200 MPa or less.
  • the elastic third layer 106 can comprise a material exhibiting an elongation to break of 200% or greater, or an elongation to break of 400% or greater.
  • the elastic third layer 106 can also take other forms, such as a tubular layer comprising an elastomeric material, a mesh, a shrinkable polymer layer such as a heat-shrink tubing layer, etc.
  • the sheath 8 may also include an elastomeric or heatshrink tubing layer around the outer layer 108. Examples of such elastomeric layers are disclosed in U.S. Publication No. 2014/0379067, U.S. Publication No. 2016/0296730, and U.S. Publication No. 2018/0008407, which are incorporated herein by reference.
  • the elastic third layer 106 can also be radially outward of the polymeric outer layer 108.
  • one or both of the inner layer 102 and/or the outer layer 108 can be configured to resist axial elongation of the sheath 8 when the sheath expands. More particularly, one or both of the inner layer 102 and/or the outer layer 108 can resist stretching against longitudinal forces caused by friction between a prosthetic device and the inner surface of the sheath 8 such that the length L remains substantially constant as the sheath expands and contracts.
  • substantially constant means that the length L of the sheath increases by not more than 1%, by not more than 5%, by not more than 10%, by not more than 15%, or by not more than 20%.
  • the filaments 110A and 110B of the braided second layer 104 can be allowed to move angularly relative to each other such that the angle 0 changes as the sheath expands and contracts.
  • This in combination with the longitudinal ridges 126 in the inner layer 102 and outer layer 108, can allow the lumen 112 of the sheath to expand as a prosthetic device is advanced through it.
  • the inner layer 102 and the outer layer 108 can be heat-bonded during the manufacturing process such that the braided second layer 104 and the elastic third layer 106 are encapsulated between the inner layer 102 and outer layer 108. More specifically, in some examples the inner layer 102 and the outer layer 108 can be adhered to each other through the spaces between the filaments 110 of the braided second layer 104 and/or the spaces between the elastic bands 116. The inner layer 102 and outer layer 108 can also be bonded or adhered together at the proximal and/or distal ends of the sheath. In some examples, the inner layer 102 and outer layer 108 are not adhered to the filaments 110.
  • the filaments 110 can move angularly relative to each other, and relative to the inner layer 102 and outer layer 108, allowing the diameter of the braided second layer 104, and thereby the diameter of the sheath, to increase or decrease.
  • the length of the braided second layer 104 can also change. For example, as the angle 0 increases, the braided second layer 104 can foreshorten, and as the angle 0 decreases, the braided second layer 104 can lengthen to the extent permitted by the areas where the inner layer 102 and outer layer 108 are bonded.
  • the braided second layer 104 is not adhered to the inner layer 102 and outer layer 108, the change in length of the braided layer that accompanies a change in the angle 0 between the filaments 110A and HOB does not result in a significant change in the length L of the sheath.
  • FIG. 14 illustrates radial expansion of the sheath 8 as a prosthetic device (for example, medical device 12) is passed through the sheath 8 in the direction of arrow 132 (for example, distally).
  • a prosthetic device for example, medical device 12
  • the sheath can resiliently expand to a second diameter D2 that corresponds to a size or diameter of the prosthetic device.
  • the prosthetic device can apply longitudinal force to the sheath in the direction of motion by virtue of the frictional contact between the prosthetic device and the inner surface of the sheath.
  • the inner layer 102 and/or the outer layer 108 can resist axial elongation such that the length L of the sheath remains constant, or substantially constant. This can reduce or prevent the braided layer second 104 from lengthening, and thereby constricting the lumen 112.
  • the angle 0 between the filaments 110A and 110B can increase as the sheath expands to the second diameter D2 to accommodate the prosthetic valve. This can cause the braided second layer 104 to foreshorten.
  • the filaments 110 are not engaged or adhered to the inner layer 102 or outer layer 108, the shortening of the braided second layer 104 attendant to an increase in the angle 0 does not affect the overall length L of the sheath.
  • the longitudinally-extending ridges 126 formed in the inner layer 102 and outer layer 108 the inner layer 102 and outer layer 108 can expand to the second diameter D2 without rupturing, in spite of being relatively thin and relatively nonelastic.
  • the sheath 8 can resiliently expand from its natural diameter DI to a second diameter D2 that is larger than the diameter DI as a prosthetic device is advanced through the sheath, without lengthening, and without constricting.
  • the force required to push the prosthetic implant through the sheath is significantly reduced.
  • the radial expansion of the sheath 8 can be localized to the specific portion of the sheath occupied by the prosthetic device.
  • the portion of the sheath immediately proximal to the prosthetic device can radially collapse back to the initial diameter DI under the influence of the elastic third layer 106.
  • the inner layer and outer layer 108 can also buckle as the circumference of the sheath is reduced, causing the ridges 126 and the valleys 128 to reform.
  • FIGS. 15-23 illustrate various features of the coaxial layered structure of the expandable sheath 8 of FIG. 1 according to another aspect. Similar reference numbers are used to describe like elements. It is to be understood that the variations (for example, materials and alternate configurations) described herein with reference to FIGS. 11-14 can also apply to the example shown in FIGS. 15-23. Furthermore, the variations described herein with reference to FIGS. 15-23 can also be applied to the sheath described in FIGS. 11-14.
  • the sheath 8 of FIGS. 15-23 includes a plurality of layers.
  • the sheath 8 illustrated in FIGS. 15-23 also includes an inner layer 202 and an outer layer 204 disposed around the inner layer 202.
  • the inner layer 202 can define a central lumen 212 through which the delivery apparatus travels into the patient’s vessel in order to deliver, remove, repair, and/or replace a prosthetic device, moving in a direction along the longitudinal axis X. Similar to the sheath illustrated in FIGS.
  • the sheath 8 locally expands from a first, resting/unexpanded diameter to a second, expanded diameter to accommodate the prosthetic device. After the prosthetic device passes through a particular location of the sheath 8, each successive expanded portion or segment of the sheath 8 at least partially returns to the smaller, resting/unexpanded diameter. In this manner, the sheath 8 can be considered self-expanding, in that it does not require use of a balloon, dilator, and/or obturator to expand.
  • the inner and outer layers 202, 204 can comprise any suitable materials. Suitable materials for the inner layer 202 include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), nylon, polyethylene, polyether block amide (for example, Pebax), and/or combinations thereof.
  • PTFE polytetrafluoroethylene
  • ETFE ethylene tetrafluoroethylene
  • nylon polyethylene
  • polyether block amide for example, Pebax
  • the inner layer 202 can comprise a lubricious, low-friction, or hydrophilic material, such as PTFE.
  • Such low coefficient of friction materials can facilitate passage of the prosthetic device through the lumen defined by the inner layer 202.
  • the inner layer 202 can have a coefficient of friction of less than about 0.1.
  • sheath 8 can include a lubricious liner on the inner surface of the inner layer 202.
  • suitable lubricious liners include materials that can further reduce the coefficient of friction of the inner layer 202, such as PTFE, polyethylene, polyvinylidene fluoride, and combinations thereof.
  • Suitable materials for a lubricious liner also include other materials desirably having a coefficient of friction of about 0.1 or less.
  • Suitable materials for the outer layer 204 include nylon, polyethylene, Pebax, HDPE, polyurethanes (for example, Tecoflex), and other medical grade materials.
  • the outer layer 204 can comprise high density polyethylene (HDPE) and Tecoflex (or other polyurethane material) extruded as a composite.
  • the Tecoflex can act as an adhesive between the inner layer 202 and the outer layer 204 and may only be present along a portion of the inner surface of the outer layer 204.
  • Other suitable materials for the inner and outer layers are also disclosed in U.S. Patent Nos. 8,690,936 and 8,790,387, which are incorporated herein by reference.
  • the sheath 8 include an exterior hydrophilic coating on the outer surface of the outer layer 204. Such a hydrophilic coating can facilitate insertion of the sheath 8 into a patient’s vessel.
  • suitable hydrophilic coatings include the Harmony TM Advanced Lubricity Coatings and other Advanced Hydrophilic Coatings available from SurModics, Inc., Eden Prairie, MN. DSM medical coatings (available from Koninklijke DSM NV, Heerlen, the Netherlands), as well as other hydrophilic coatings (for example, PTFE, polyethylene, poly vinylidene fluoride), are also suitable for use with the sheath 8.
  • FIGS. 15-23 illustrate an example sheath system 200.
  • FIG. 16 provides a partial cross-section of the distal end of the sheath 8 along section line 16-16 identified in FIG. 15.
  • the sheath 8 can be inserted into a vessel (for example, the femoral or iliac arteries) by passing through the skin of patient, such that a soft tip portion 206 at the distal end 210 of the sheath 8 is inserted into the vessel.
  • the soft tip portion 206 can comprise, in some examples, low density polyethylene (LDPE) and can be configured to minimize trauma or damage to the patient’s vessels as the sheath is navigated through the vasculature.
  • LDPE low density polyethylene
  • the soft tip portion 206 can be slightly tapered to facilitate passage through the vessels.
  • the soft tip portion 206 can be secured to the distal end 210 of the sheath 8, such as by thermally bonding the soft tip portion 206 to the inner and outer layers of the sheath 8.
  • Such a soft tip portion 206 can be provided with a lower hardness than the other portions of the sheath 8.
  • the soft tip portion 206 can have a Shore hardness from about 25D to about 40D.
  • the soft tip portion 206 is configured to be radially expandable to allow a prosthetic device to pass through the distal opening of the sheath 8.
  • the soft tip portion 206 can be formed with a weakened portion, such as an axially extending score line or perforated line that is configured to split and allow the soft tip portion 206 to expand radially when the prosthetic device passes therethrough.
  • FIG. 17 shows a cross-sectional view of the sheath 8 taken near the distal end 210 of the sheath 8 as indicated by section line 17-17 in FIG. 16.
  • the sheath 8 can include at least one radiopaque filler or marker, such as a discontinuous, or C-shaped, band/marker 216 positioned near the distal end 210 of the sheath 8.
  • the marker 216 can be associated with the inner and/or outer layers 202, 204 of the sheath 8.
  • the marker 216 can be positioned between the inner layer 202 and the outer layer 204.
  • the marker 216 can be associated with the outer surface of the outer layer 204.
  • the marker 216 can be embedded or blended within the inner or outer layers 202, 204.
  • FIGS. 18 and 19 show additional cross-sections taken at different points along the sheath 8.
  • FIG. 18 shows a cross-section of a segment of the sheath near the proximal end 214 of the sheath 8, as indicated by section line 18-18 in FIG. 15.
  • the sheath 8 includes the inner layer 202, outer layer 204, elastic outer layer 250/outer jacket, and the strain relief layer 26.
  • the inner and outer layers 202, 204 are substantially tubular.
  • the inner and outer layers 202, 204 can be formed without any slits or folded portions in the layers.
  • the inner and outer layers 202, 204 at different locations along the sheath 8 can have a different configuration.
  • the inner layer 202 can be arranged to form a substantially cylindrical central lumen 212 therethrough.
  • Inner layer 202 can include one or more folded portions 218.
  • inner layer 202 is arranged to have one folded portion 218 that can be positioned on either side of the inner layer 202.
  • Inner layer 202 can be continuous, in that there are no breaks, slits, or perforations in inner layer 202.
  • Outer layer 204 can be arranged in an overlapping fashion such that an overlapping portion 220 overlaps at least a part of the folded portion 218 of the inner layer 202. As shown in FIG. 19, the overlapping portion 220 also overlaps an underlying portion 222 of the outer layer 204.
  • the underlying portion 222 can be positioned to underlie both the overlapping portion 220 of the outer layer 204, as well as the folded portion 218 of the inner layer 202.
  • the outer layer 204 can be discontinuous, in that it includes a slit or a cut in order to form the overlapping portion 220 and underlying portion 222.
  • a first edge 224 of the outer layer 204 is spaced apart from a second edge 225 of the outer layer 204 so as not to form a continuous layer.
  • the sheath 8 can also include a thin layer of bonding or adhesive material 228 positioned between the inner layer 202 and outer layer 204.
  • the adhesive material 228 can comprise a polyurethane material such as Tecoflex.
  • the adhesive material 228 can be positioned on an inner surface 230 of at least a portion of the outer layer 204 so as to provide adhesion between selected portions of the inner layer 202 and outer layer 204.
  • the outer layer 204 may only include a Tecoflex layer (adhesive material 228) around the portion of the inner surface 230 that faces the lumenforming portion of the inner layer 202.
  • the Tecoflex layer (adhesive material 228) can be positioned so that it does not contact the folded portion 218 of the inner layer 202 in some examples.
  • the Tecoflex can be positioned in different configurations as desired for the particular application. For example, as shown in FIG. 19, the Tecoflex layer can be positioned along the entire inner surface 230 of the outer layer 204. In some examples, the Tecoflex layer can be applied to the outer surface of the inner layer 202 instead of the inner surface of the outer layer 204.
  • the Tecoflex layer can be applied to all or selected portions on the inner layer 202; for example, the Tecoflex layer can be formed only on the portion of the inner layer 202 that faces the lumen-forming portion of the outer layer 204 and not on the folded portion 218.
  • the configuration of FIG. 19 allows for radial expansion of the sheath 8 as an outwardly directed radial force is applied from within (for example, by passing a medical device such as a prosthetic heart valve through the central lumen 212).
  • the folded portion 218 can at least partially separate, straighten, and/or unfold, and/or the overlapping portion 220 and the underlying portion 222 of the outer layer 204 can slide circumferentially with respect to one another, thereby allowing the diameter of central lumen 212 to enlarge.
  • the sheath 8 is configured to expand from a resting/unexpanded configuration (FIG. 19) to an expanded configuration shown in FIG. 20.
  • a gap 232 can form between the longitudinal edges of the overlapping portion 220 and the underlying portion 222 of the outer layer 204.
  • the overlapping portion 220 of the outer layer 204 can move circumferentially with respect to the underlying portion 222 as the folded portion 218 of the inner layer 202 unfolds. This movement can be facilitated by the use of a low-friction material for inner layer 202, such as PTFE.
  • the folded portion 218 can at least partially separate and/or unfold to accommodate a medical device having a diameter larger than that of central lumen 212 in the resting/unexpanded configuration. As shown in FIG. 20, in some examples, the folded portion of the inner layer 202 can completely unfold, so that the inner layer 202 forms a cylindrical tube at the location of the expanded configuration.
  • the sheath 8 is configured to locally expands at a particular location corresponding to the location of the medical device along the length of the central lumen 212, and then locally contracts once the medical device has passed that particular location.
  • a bulge may be visible, traveling longitudinally along the length of the sheath 8 as a medical device is introduced through the sheath 8, representing continuous local expansion and contraction as the device travels the length of the sheath 8.
  • Each segment of the sheath 8 will locally contract after removal of any radial outward force such that the sheath 8 at least partially returns to the original resting/unexpanded diameter of central lumen 212.
  • an elastic outer layer 250 can (optionally) be provided along the sheath 8, urging the inner and outer layers 202, 204 back to the unexpanded configuration.
  • the layers 202, 204 of sheath 8 can be configured having the folded portion 218 as shown in FIG. 19 along at least a portion of the length of the sheath 8.
  • the inner and outer layers 202, 204 can be configured as shown in FIG. 19 along the length A (FIG. 15) such that the folded portion 218 extends from a location adjacent the soft tip portion 206 to a location closer to the proximal end 214 of the sheath 8, adjacent and/or under the distal end of the strain relief layer 26.
  • the sheath 8 is expandable and contractable only along a portion of the length of the sheath corresponding to length A (which can correspond to the section of the sheath inserted into the narrowest section of the patient’s vasculature).
  • the folded portion 218 portion extends from a location adjacent the soft tip portion 206 under the strain relief layer 26, as illustrated in FIG. 21.
  • the folded structure of the inner layer 202 extends from the soft tip portion 206, under the strain relief layer 26 and along the tapered portion 248 of the strain relief layer 26.
  • FIGS. 22 and 23 illustrate cross-sectional views of the sheath 8 taken along the strain relief layer 26 at section line 22-22 in FIG. 21.
  • the folded portion 218 of the inner layer 202 extends under the strain relief layer 26.
  • FIG. 22 shows a cross-section of the sheath 8 in a resting/unexpanded configuration having an inner diameter DI.
  • FIG. 23 shows a cross-section of the sheath 8 in a (partially) expanded configuration, having an inner diameter D2, where D2 is greater than DI.
  • the overlapping portion 220 does not overlap the entire folded portion 218 of the inner layer 202, and thus a portion of the folded portion 218 can be directly adjacent to the strain relief layer 26 in locations where the strain relief layer 26 is present. In locations where the strain relief layer 26 is not present, part of the folded portion 218 may be visible from the outside of the sheath 8, as seen in FIG. 21 (and/or visible through an elastic outer layer 250 described in more detail herein).
  • the sheath 8 can include a longitudinal seam 234 where the overlapping portion 220 terminates at the folded portion 218.
  • the sheath 8 can be positioned such that the seam 234 is posterior to the point of the sheath that is 180 degrees from the seam 234 (for example, facing downward in the view of FIG. 21). As shown in FIG. 21, the seam 234 need not extend the entire length of the sheath 8, and end at a transition point between portions of the sheath having a folded inner layer and portions of the sheath not having a folded inner layer.
  • the folded portion 218 can include a weakened portion 236, such as a longitudinal perforation, score line, and/or slit, along at least a portion of the length of the inner layer 202.
  • the weakened portion 236/slit allows for the two adjacent ends 238, 240 of the folded portion 218/inner layer 202 to move relative to one another as the sheath 8 expands to the expanded configuration shown in FIG. 23.
  • the sheath 8 locally expands as a medical device is inserted therethrough, causing the weakened portion 236 to split/separate.
  • the sheath 8 may include an elastic outer layer 250 that expands with the sheath 8.
  • the elastic outer layer 250 can provide an inwardly directed radial force that directs the sheath to a folded/unexpanded configuration. Similar to the strain relief layer 26, elastic outer layer 250 can also provide hemostasis (for example, prevent blood loss during implantation of the prosthetic device).
  • the elastic outer layer 250 can be positioned around at least a portion of the strain relief layer 26, outer layer 108, 204 and/or the inner layers of the sheath 8. As illustrated in FIGS. 21-23, the elastic outer layer 250 can surround the entire circumference of outer layer 204, and can extend longitudinally along any portion of the length of the sheath 8, including along (over or under) the strain relief layer 26. The elastic outer layer 250 extends for a length along at least a portion of the main body of the sheath 8. In some examples, the elastic outer layer 250 extends to a point adjacent the distal end 210, or can extend all the way to the distal end 210 of sheath 8. For example, the elastic outer layer 250 extends over the entire length of the sheath 8.
  • the elastic outer layer 250 can be a continuous tubular layer, without slits or other discontinuities.
  • the elastic outer layer 250 extends between strain relief layer 26 and the outer surface of the outer layer 204. In some examples, the elastic outer layer 250 extends over the outer surface of the strain relief layer 26 and the outer surface of the outer layer 204. In some examples, the elastic outer layer 250 extends both over the strain relief layer 26 and/or between the outer layer of the sheath 8 and the strain relief layer 26.
  • the elastic outer layer 250 can comprise any pliable, elastic material(s) that expand and contract, preferably with a high expansion ratio.
  • the materials used can include low durometer polymers with high elasticity, such as Pebax, polyurethane, silicone, and/or polyisoprene.
  • Materials for the elastic outer layer 250 can be selected such that it does not impede expansion of the inner and outer layers of the sheath 8.
  • the elastic outer layer 250 can have a thickness ranging from, for example, about 0.001 inches to about 0.010 inches. In some examples, the elastic outer layer 250 can have a thickness of about 0.003 inches to about 0.006 inches.
  • the elastic outer layer 250 can be configured to stretch and expand as the sheath expands, as shown in the expanded configuration in FIG. 20.
  • the sheath 8 in each of the examples described herein may include a strain relief layer 26.
  • the strain relief layer 26 is provided adjacent the proximal end of the sheath 8 and extends along/over the outer surface of the sheath 8.
  • the strain relief layer 26 is provided over the outer layer 108, 204 of the sheath 8.
  • the strain relief layer 26 forms a smooth transition between the sheath hub 20 and the sheath 8 and facilitates mating of the sheath 8 with the sheath hub 20.
  • the strain relief layer 26 provides a region of higher durometer or stiffness that restricts expansion of the underlying sheath layers. This helps to ensure hemostasis between the portions of the sheath 8 inside the patient and the sheath hub (external to the patient).
  • the increased durometer and/or stiffness along the strain relief layer 26 prevents blood from flowing between the various layers of the sheath 8 exterior to the patient during the procedure, helping to withstand the blood pressure that would otherwise cause the sheath to “balloon up” with body fluid/blood.
  • the strain relief layer 26 can be sized and configured to form a seal with the patient’s artery when inserted, such that blood is substantially prevented from flowing between the strain relief layer 26 and the vessel wall.
  • the strain relief layer 26 does not extend all the way to the distal end 210 of the sheath 8
  • the strain relief layer 26 can extend distally enough along the sheath 8 that when the sheath 8 is fully inserted into the patient a portion of the strain relief layer 26 extends through and seals against the arteriotomy site.
  • the strain relief layer 26 is provided over the outer layer 108, 204 of the sheath 8.
  • the strain relief layer 26 can be bonded to the outer layer 108, 204 to prevent the strain relief layer 26 from sliding over the outer layer and “bunching up” in response to the friction forces applied by the surrounding tissue during insertion of the sheath 8 into the patient’ s vasculature.
  • the strain relief layer 26 can be bonded at the proximal end and/or distal end of the outer layer 108, 204. At the proximal and distal ends, the strain relief layer 26 can be bonded to the outer layer 204 around the full circumference of the outer layer.
  • the strain relief layer 26 can additionally and/or alternatively be bonded to the inner layer(s) of the sheath 8.
  • the strain relief layer 26 can be bonded to the distal end surface of the inner layer 102, 202.
  • FIGS. 18, 22 and 23 illustrate cross-sectional views of the sheath 8 along the strain relief layer 26.
  • FIG. 18 shows a cross-section of a segment of the sheath near the proximal end 214 of the sheath 8, as indicated by line 18-18 in FIG. 15.
  • FIGS. 22 and 23 show cross-section segments of various example sheaths near the proximal end 214 of the sheath 8 and closer to the distal end of the strain relief layer 26, as indicated by section line 22-22 in FIG. 21.
  • the sheath 8 at this location can comprise a liner/inner layer 202, outer layer 204, adhesive material 228, an optional elastic outer layer 250, and the strain relief layer 26.
  • the strain relief layer 26 extends circumferentially around at least a portion of the inner layer 202 and outer layer 204.
  • the strain relief layer 26 extends from the proximal end 214 of the sheath 8 towards the distal end 210 of the sheath 8.
  • the strain relief layer 26 extends for a length L along at least a portion of the main body of the sheath 8.
  • the strain relief layer 26 extends to a point adjacent the distal end 210, or can extend all the way to the distal end 210 of sheath 8.
  • the longitudinal length L of the strain relief layer 26 can range from about 10 cm to the entire length of the sheath 8.
  • the strain relief layer 26 extends to/adjacent the proximal end 214 of the sheath 8 and provides a compression fit over the distal end of the sheath hub 20 thereby coupling the sheath 8 to the sheath hub 20. Additionally, or alternatively, the strain relief layer 26 secured between the sheath hub 20 and the sheath hub cap 22 or other fastening device for by coupling the proximal end of the sheath to the sheath hub 20. In some examples, the strain relief layer 26 does not extend all the way to the proximal end 214 of the sheath 8.
  • strain relief layer 26 can have similar composition and characteristics of the inner and outer layers as disclosed herein.
  • Various compositions are disclosed, for example, in Application No. PCT/US2021/301275, entitled “Expandable sheath for introducing an endovascular delivery device into a body,” the disclosure of which is herein incorporated by reference.
  • the strain relief layer 26 can comprise any lubricious, low-friction, and/or relatively non-elastic material.
  • the materials used can include high durometer polymers, with low elasticity.
  • the strain relief layer 26 is composed of the same and/or similar material to the inner layer 202 and/or outer layer 204.
  • exemplary materials can include polyurethane (for example, high density polyethylene), ultra-high-molecular-weight polyethylene (UHMWPE) (for example, Dyneema®), high-molecular-weight polyethylene (HMWPE), or poly ether ether ketone (PEEK).
  • strain relief layer 26 can include poly imide, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), ethylene tetrafluoroethylene (ETFE), nylon, polyethylene, polyamide, polyether block amide (for example, Pebax), and/or combinations of any of the herein. Materials for the strain relief layer 26 can be selected such that it impedes expansion of the underlying layers of the sheath 8.
  • PTFE polytetrafluoroethylene
  • ePTFE expanded polytetrafluoroethylene
  • ETFE ethylene tetrafluoroethylene
  • nylon polyethylene
  • polyamide polyamide
  • polyether block amide for example, Pebax
  • the strain relief layer 26 can have a thickness ranging from, for example, about 0.001 inches to about 0.010 inches. In some examples, the strain relief layer 26 can have a thickness of from about 0.003 inches to about 0.006 inches. The wall thickness is measured radially between the inner surface of the strain relief layer 26 and the outer surface of the strain relief layer 26.
  • the material composition and/or wall thickness can change along the length of the strain relief layer 26.
  • the strain relief layer 26 can be provided with one or more segments, where the composition and/or thickness changes from segment to segment.
  • the Durometer rating of the composition changes along the length of the strain relief layer 26 such that segments near the proximal end comprise a stiffer material or combination of materials, while segments near the distal end comprise a softer material or combination of materials.
  • the wall thickness of the strain relief layer 26 in segments near the proximal end can be thicker/greater than the wall thickness of the elastic outer layer 250 near the distal end.
  • the strain relief layer 26 has a proximal end and a distal end and a central lumen extending longitudinally therethrough.
  • the strain relief layer 26 includes a generally tubular shaped proximal portion 242 adjacent the proximal end of the strain relief layer 26, and a generally tubular shaped distal portion 246 adjacent the distal end of the strain relief layer 26.
  • the strain relief layer 26 includes a frustoconical shaped tapered portion 248 extending between the proximal portion 242 and the distal portion 246 of the strain relief layer 26, such that the diameter of the strain relief layer 26 at the proximal portion 242 is greater than the diameter of the strain relief layer 26 at the distal portion 246 of the strain relief layer 26.
  • the tapered portion 248 and the flared proximal portion 242 help ease the transition of the medical device/delivery apparatus when passing between the larger diameter sheath hub 20 to the smaller diameter of the sheath 8.
  • the strain relief layer 26 is made of a material that is stiffer than the other sheath 8 layers such that the strain relief layer 26 inhibits expansion of the portion of the sheath disposed along/under the strain relief layer 26. Because radial expansion is limited along the strain relief layer 26, higher push forces are necessary to advance the medical device through the central lumen of the sheath 8. In some examples, the highest push forces through the sheath 8 are experienced near the proximal and distal ends of the sheath 8, through the strain relief layer 26 (for example, through the tapered portion of the strain relief layer 26), and at proximal and distal ends of the strain relief layer 26.
  • the thickness and/or composition of the strain relief layer 26 and/or sheath 8 can be adjusted to improve the performance of the sheath 8 and reduce the push force.
  • dilating or expanding the sheath 8 (or a portion thereof) before the medical device/delivery apparatus is introduced helps to reduce the initial push force through the sheath 8.
  • Pre-dilating the sheath 8 releases and/or loosens any bonding or adhesion of the sheath 8 layers that occurs during the manufacturing process, for example, bonding between the inner and outer layers 202, 204, bonding between the folded portion 218 and outer layer 204, bonding between the inner/outer layers and the strain relief layer 26. Pre-dilating can also break or separate the weakened portion 236 of folded portion 218 of the inner layer 202, separating adjacent ends 238, 240 of the folded portion 218, as described herein and illustrated in FIG. 23. With the sheath 8 layers able to move freely with respect to the other, the medical device/delivery apparatus is pushed through the sheath 8 lumen at a much lower force.
  • introducer sheaths are often designed for use via femoral approach. Accordingly, introducer sheaths typically have a length sufficient to extend from a femoral access site through the femoral artery and into the abdominal aorta.
  • this configuration is not well-suited for alternative approaches (such as carotid, subclavian, and axillary approaches).
  • FIG. 24 shows introducer sheaths introduced at the femoral access site SF, the carotid access site Sc, the axillary access site SA, and the subclavian access site Ss.
  • sheath systems 300, 400, and 500 are disclosed herein with reference to FIGS. 25-32. These sheath systems and methods facilitate setting/adjusting the length of a sheath to reduce the length of the sheath that extends outside of the patient while avoiding these problems. It is contemplated herein that the sheath systems 300, 400, and 500 can be used individually and/or with other components described herein in reference to FIGS. 1-23, such as the delivery apparatus 10 or the prosthetic device 12. Additionally, it is contemplated that the sheath systems 300 can be formed and used individually and/or be integrated into another expandable sheath, including the sheath 8 as described herein or sheaths having different layered sheath structures than those described herein.
  • the sheaths 308 provided herein can have any of the attributes provided above with respect to sheath 8.
  • the sheaths 308 can include a continuous inner layer and one or more additional layers disposed radially outward of the inner layer, such as a second layer, a third layer (also referred to as an elastic layer), and/or a fourth layer (also referred to as an outer layer).
  • the sheath 308 can include at least one folded portion extending along a length of the inner layer.
  • the folded portion can at least partially separate, straighten, and/or unfold, thereby allowing a diameter of a central lumen 312 of the sheath 308 to enlarge.
  • the sheath 308 is configured to radially expand from a resting/unexpanded configuration to an expanded configuration.
  • the present disclosure provides various methods for setting the length of the sheath 308 that include severing/cutting the sheath 308, thereby dividing the sheath 308 into one or more sections.
  • the terms “initial distal end” and “initial proximal end” correspond to the distal end 310 and the proximal end 314 of the sheath 308 before it is cut. After the sheath 308 is cut, one or more ends of the one or more sections of the sheath 308 will be newly formed. Newly formed ends of the sheath 308 created by the act of cutting the sheath 308 are herein referred to as “second” or “third” ends.
  • FIG. 25 illustrates side views of an example introducer sheath system 300 including an example sheath 308 that has an initial distal end 310 and an initial proximal end 314 and defines a central lumen 312 extending therebetween along the longitudinal axis X.
  • the sheath 308 has an initial sheath length LI, which corresponds to the distance between the initial distal end 310 and the initial proximal end 314 of the sheath 308.
  • the illustrated introducer sheath system 300 includes an initial sheath hub 340.
  • the initial sheath hub 340 has a hub body 342 extending between a proximal end 344 and a distal end 346 of the initial sheath hub 340 and defines a central lumen 348 extending longitudinally therethrough. It is contemplated that the initial sheath hub 340 provided herein can have any of the attributes provided above with respect to the sheath hub 20. As shown, the distal end 346 of the initial sheath hub 340 is coupled to the initial proximal end 314 of the sheath 308.
  • FIG. 25 provides a method for setting the length of the sheath 308 in the introducer sheath system 300.
  • the method includes cutting the sheath 308 at a cut location 316 that is between the initial distal end 310 and the initial proximal end 314.
  • cutting the sheath 308 at cut location 316 divides the sheath 308 into a first section 302 and a second section 304.
  • the first section 302 corresponds to a portion of the sheath 308 distal to the cut location 316 and the second section 304 corresponds to a portion of the sheath 308 proximal to the cut location 316.
  • the first section 302 extends between the initial distal end 310 and a second proximal end 314’ formed directly distal of the cut location 316.
  • a distance between the initial distal end 310 and a second proximal end 314’ defines a first section length L2 of the first section 302.
  • the second section 304 extends between a second distal end 310’ formed directly proximate of the cut location 316 and the initial proximal end 314.
  • a second sheath hub 340’ is introduced. Accordingly, the method further includes coupling the second sheath hub 340’ to the first section 302. Specifically, the distal end 346’ of the second sheath hub 340’ is coupled to the second proximal end 314’ of the first section 302. As shown, a second lumen 348’ of the second sheath hub 340’ is aligned with the central lumen 312 of the sheath 308 to facilitate passage of the delivery apparatus 10/medical device 12 therethrough.
  • this method of setting the length of the sheath 308 facilitates reducing the length of the sheath 308 while conserving the initial distal end 310.
  • the second sheath hub 340’ has all the attributes of the initial sheath hub 340.
  • the second sheath hub 340’ can be configured differently from the initial sheath hub 340, so long as the second sheath hub 340’ is couplable to the second proximal end 314’ of the first section 302 of the sheath 308.
  • the first section length L2 is based on a length of the sheath 308 to be inserted into the patient’s vasculature Lmsertion, which is defined by the distance between the incision site and the treatment site.
  • the axial position of the cut location 316 can be selected anywhere along the sheath 308 such that the first section length L2 is equal to or greater than the insertion length Linsertion.
  • the first section length L2 can optionally he approximately the same as insertion length Li, lser tion so as to reduce the portion of the sheath 308 extending outside of the patient’s body during the procedure.
  • the desired insertion length Lmsertion and corresponding first section length L2 can vary depending on patient size and anatomy, as well as physician preferences.
  • cutting the sheath 308 includes cutting the sheath 308 at a cut angle relative to the longitudinal axis X of the sheath 308.
  • FIG. 25 shows the sheath 308 cut a 90° angle relative to the longitudinal axis X of the sheath 308.
  • the sheath 308 can be cut at various angles relative to the longitudinal axis X of the sheath so long as the second proximal end 314’ of the first section 302 of the sheath 308 remains couplable to the second sheath hub 340’.
  • the sheath 308 can be cut at an angle of 90° to 135° relative to the longitudinal axis X.
  • the sheath 308 can be cut at an angle of 90° to 105° relative to the longitudinal axis X. In some examples, the sheath 308 can be cut at an angle of 90° to 95° relative to the longitudinal axis X.
  • cutting the sheath 308 at an angle at or near 90° facilitates easier coupling with the second sheath hub 340’.
  • the sheath 308 is configured to facilitate passage of the delivery apparatus 10/medical device 12 through an incision site and to a treatment site within a patient’s body.
  • the insertion length Lmsertion, and accordingly, the desired first section length L2 is determined before any portion of the sheath 308 is inserted into the incision site. This allows the sheath 308 to be cut away from the patient’s body.
  • the sheath 308 can be inserted at least partially into a blood vessel at the incision site and advanced toward the treatment site.
  • a medical device 12 such as a prosthetic heart valve
  • the medical device 12 exerts an outwardly directed radial force against an inner layer of the sheath 308.
  • This causes the sheath 308 to locally expand from the unexpanded configuration to the expanded configuration at a location proximate the medical device 12.
  • an inner layer of the sheath 308 can include at least one folded portion. Locally expanding the central lumen 312 of the sheath 308 causes a length of the folded portion to at least partially unfold.
  • the sheath 308 locally contracts at least partially back to the unexpanded configuration.
  • the medical device 12 can be advanced beyond a distal opening at the initial distal end 310 of the sheath 308 and toward the treatment site.
  • the dilator 6 (also referred as an introducer) as described herein is advanced into the central lumen 312 of the sheath 308 through the lumen 348’ of the second sheath hub 340’.
  • the sheath 308 can be inserted at least partially into a blood vessel at the insertion site with the dilator 6 disposed within the sheath 308.
  • the rigidity of the dilator 6 helps to expand the patient’s blood vessel.
  • the dilator 6 can be withdrawn from the central lumen 312 of the sheath 308 and the delivery apparatus 10 can be introduced.
  • the medical device 12 described herein can include a prosthetic device mounted in a radially crimped state on the delivery apparatus 10, and the act of advancing the prosthetic device through the central lumen 312 of the sheath 308 can comprise advancing the delivery apparatus 10 and the prosthetic device through central lumen 312 of the sheath 308 and into the vasculature of the patient.
  • the prosthetic device comprises a prosthetic heart valve and the method further comprises implanting the prosthetic heart valve at the treatment site within the patient.
  • the prosthetic heart valve is mounted on a balloon catheter of the delivery apparatus 10 as the prosthetic heart valve is advanced through the sheath 308.
  • sheath hub 340 it may be desirable to adjust the length of the sheath 308 while conserving both the initial distal end 310 and the initial sheath hub 340 (hereafter referred to as simply the “sheath hub 340”).
  • One possible solution is to cut the sheath 308 at two axial cut locations spaced apart from one another along the length of the sheath 308 and disposing of a central section of the sheath defined between the two cut locations.
  • an obstacle arises based on the need to recouple the section of the sheath 308 comprising the initial distal end 310 to the sheath hub 340.
  • FIGS. 26-29B refer to an example sheath coupling system 400 including a sheath 308, a sheath hub 340 disposed proximal to the sheath 308, and an initial hub cap 320 coupled to the sheath hub 340.
  • the sheath coupling system 400 further includes a hub coupler 360 for coupling the sheath 308 to a second hub cap 320’ after the length of the sheath 308 has been adjusted, thereby recouping the sheath 308 to the sheath hub 340.
  • the hub coupler 360 facilitates the removal of an intermediate length of sheath 308, (for example, second section 304 of sheath 308, as shown in FIG.
  • the example sheath 308 illustrated in FIGS. 26 and 27 can have any of the attributes of the example sheath 308 provided above with respect to FIG. 25. Accordingly, the sheath 308 has an initial sheath length LI, which corresponds to the distance between the initial distal end 310 and the initial proximal end 314 of the sheath 308.
  • sheath hub 340 illustrated in FIGS. 26 and 27 can have any of the attributes of the sheath hub 340 provided above with respect to FIG. 25.
  • the sheath coupling system 400 also includes an initial hub cap 320 for securing the sheath 308 to the sheath hub 340 prior to setting the length of the sheath 308. It is contemplated that the initial hub cap 320 can have any of the attributes of the hub cap 22 provided above with respect to FIGS. 2-6.
  • the initial hub cap 320 includes a proximal end 324 and a distal end 326 and defines a lumen extending longitudinally therethrough. As shown, the initial hub cap 320 receives the distal end 346 of the sheath hub 340, thereby coupling the initial hub cap 320 to the sheath hub 340.
  • the initial hub cap 320 comprises a radially inwardly extending threaded region 330 defined adjacent the proximal end 324 of the initial hub cap 320. This threaded region 330 threadingly engages a complementary radially outwardly extending threaded region defined adjacent the distal end 346 of the sheath hub 340.
  • the initial proximal end 314 of the sheath 308 is positioned between the distal end 326 of the initial hub cap 320 and the distal end 346 of the sheath hub 340 such that coupling the initial hub cap 320 to the sheath hub 340 fixes the sheath 308 to the initial hub cap 320 and to the sheath hub 340.
  • the sheath coupling system 400 includes a hub coupler 360 that has a body 362 extending between a proximal end 364 and a distal end 366 and defining a lumen 368 extending longitudinally therethrough.
  • the proximal end 364 of the hub coupler 360 has a diameter that is radially expanded relative to a diameter of the distal end 366.
  • the proximal end 364 of the hub coupler 360 is configured to receive the distal end 366 of the initial hub cap 320.
  • an inner surface 370 of the hub coupler body 362 has a profile that complements an outer surface of the initial hub cap 320.
  • the hub coupler 360 further includes a tab 372 extending radially inward from the hub coupler body 362. As shown in FIG. 27, the tab 372 is configured to couple with a gap 350 formed between the sheath hub 340 and the proximal end 324 of the initial hub cap 320. In the illustrated example, the tab 372 extends circumferentially about the proximal end 364 of the hub coupler 360. Furthermore, as shown in FIG. 27 and further described herein, the distal end 366 of the hub coupler 360 comprises a radially outwardly extending threaded region 374 defined adjacent the distal end 366 of the hub coupler 360.
  • the sheath coupling system 400 includes a second hub cap 320’ for securing the sheath 308 to the sheath hub 340 after adjusting the length of the sheath 308. It is contemplated that the second hub cap 320’ can have any of the attributes of the initial hub cap 320. Accordingly, as shown in FIG. 27, the second hub cap 320’ includes a proximal end 324’ and a distal end 326’ and defines a lumen extending longitudinally therethrough.
  • second hub cap 320’ is disposed distal to the initial hub cap 320.
  • the second hub cap 320’ is configured to receive the distal end 366 of the hub coupler 360, thereby coupling the second hub cap 320’ and the hub coupler 360.
  • the second hub cap 320’ comprises a radially inwardly extending threaded region 330’ defined adjacent the proximal end 324’ of the second hub cap 320’. This threaded region 330’ threadingly engages the complementary radially outwardly extending threaded region 374 defined adjacent the distal end 366 of the hub coupler 360.
  • a coupler seal 390 can be disposed between the distal end 366 of the hub coupler 360 and the threaded region 330’ of the second hub cap 320’, thereby reducing the risk of fluid leaking between the coupling.
  • the coupler seal 390 is formed as rubber O-ring and extends around the distal end 366 of the hub coupler 360 adjacent a distal end of the threaded region 330’.
  • the coupler seal 390 can be formed as a sleeve that extends over the distal end 366 of the hub coupler 360 and around a portion of the sheath 308 (for example, the first section 302).
  • the coupler seal 390 can be formed from any compliant material that is capable of reducing fluid leakage between the coupling formed between the hub coupler 360 and the second hub cap 320’, such as silicone.
  • the initial proximal end 314 of the sheath is positioned between the distal end 326 of the initial hub cap 320 and the distal end 346 of the sheath hub 340 such that coupling the initial hub cap 320 to the sheath hub 340 fixes the sheath 308 to the initial hub cap 320 and to the sheath hub 340.
  • adjusting the length of the sheath 308 forms a section of the sheath 308 having a newly formed proximal end (for example, the third proximal end 314” as described further herein). As provided herein and shown in FIG.
  • the newly formed third proximal end 314” of the sheath 308 is positioned between the distal end 326’ of the second hub cap 320’ and the distal end 366 of the hub coupler 360 such that coupling the second hub cap 320’ to the hub coupler 360 fixes the length-adjusted sheath 308 to the hub coupler 360 and to the sheath hub 340.
  • the distal end 366 of the hub coupler 360 can serve as a functional substitute for the distal end 346 of the sheath hub 340 that is already coupled to the initial hub cap 320.
  • this configuration facilitates coupling a length-adjusted sheath having a newly formed proximal end (for example, the third proximal end 314”) to the same sheath hub 340 that was (and possibly remains) coupled to the initial proximal end 314 of the sheath 308.
  • the initial hub cap 320 is directly coupled to the sheath hub 340 by engagement of complementary threading; the proximal end 364 of hub coupler 360 is directly coupled to the initial hub cap 320 and sheath hub 340 by a snap fit; and the second hub cap 320’ is directly coupled to the distal end 366 of the hub coupler by engagement of complementary threading.
  • the hub coupler 360 may be directly or indirectly coupled to any one of the proximal end 314 of the sheath 308, the hub cap 320, and/or the sheath hub 340 by at least one of a press fit, an interference fit, a snap fit, a mechanical fastener, a weld and/or an adhesive.
  • an inner diameter of the sheath 308 gradually tapers from the initial proximal end 314 to the initial distal end 310. Accordingly, adjusting the length of the sheath 308 by cutting the sheath 308 to form a section of sheath 308 having a reduced length also forms new ends of the sheath having an inner diameter that varies based on the axial location of the cut. In some instances, the newly formed proximal end of the sheath 308 (such as the third proximal end 314’ ’) thus has an inner diameter that is smaller than a diameter of the initial proximal end 314 of the sheath 308 prior to cutting.
  • the sheath coupling system 400 can optionally include an adapter 380.
  • the adapter 380 includes a body 382 having a proximal end 384 and a distal end 386 and defining a lumen 388 extending longitudinally therethrough.
  • the adapter 380 tapers from the proximal end 384 toward the distal end 386.
  • the proximal end 384 has a first adapter diameter DAI and the distal end 366 has a second adapter diameter DA2 that is less than the first adapter diameter DAI.
  • the example adapter 380 illustrated in FIG. 28 is shown coupled to the distal end 366 of the hub coupler 360. Accordingly, the proximal end 384 of the adapter 380 is sized and configured to receive the distal end 366 of the hub coupler 360 and the distal end 386 of the adapter 380 is sized and configured to be received within a proximal end of the sheath 308 (such as the third proximal end 314”).
  • the adapter 380 thus accounts for a decreased inner diameter of the newly formed proximal end of the sheath 308 (such as the third proximal end 314”) relative to the inner diameter of the initial distal end 310 of the sheath 308.
  • the adapter 380 can be used to couple alternate sheaths to the sheath hub 340.
  • the adapter 380 can facilitate coupling of the smaller inner diameter sheath to the sheath hub 340.
  • an example adapter 380 is shown coupled to the second hub cap 320’. Accordingly, in this example, the adapter 380 is sized and configured to receive the distal end 326’ of the second hub cap 320’ and is sized and configured to be received within a proximal end of the sheath 308 (such as the third proximal end 314”).
  • the adapter 380 thus accounts for a decreased inner diameter of the newly formed proximal end of the sheath 308 (such as the third proximal end 314”) relative to the inner diameter of the initial distal end 310 of the sheath 308 where the decrease in inner diameter prevents the newly formed proximal end of the sheath 308 from being positioned between the distal end 326’ of the second hub cap 320’ and the distal end 366 of the hub coupler 360.
  • FIGS. 29A-29B a method for setting the length of the sheath 308 in the introducer sheath system 300 is provided.
  • the method includes cutting the sheath 308 at a first cut location 317 that is between the initial distal end 310 and the initial proximal end 314 and cutting the sheath 308 at a second cut location 318 that is between the first cut location 317 and the initial distal end 310.
  • cutting the sheath 308 at the first cut location 317 and the second cut location 318 divides the sheath 308 into a first section 302, a second section 304, and a third section 306.
  • the first cut location 317 forms a second distal end 310’ and a second proximal end 314’ on either side of the first cut location 317 and at least temporarily uncouples a portion of the sheath 308 from the sheath hub 340.
  • the third section 306 extends between the initial proximal end 314 and the second distal end 310’.
  • a distance between the initial proximal end 314 and the second distal end 310’ defines a third section length L4.
  • the first cut location 317 is selected to be axially adjacent the distal end 326 of the initial hub cap 320.
  • this reduces the residual length L4 of the third section 306 that remains after the cut.
  • FIG. 29A also shows that the second cut location 318 forms a third distal end 310’ ’ and a third proximal end 314” on either side of the second cut location 318.
  • the second section 304 extends between the second proximal end 314’ and the third distal end 310”.
  • a distance between the second proximal end 314’ and the third distal end 310’ ’ defines a second section length L3.
  • the first section 302 corresponds to a portion of the sheath extending between the third proximal end 314” and the initial distal end 310.
  • a distance between the third proximal end 314” and the initial distal end 310 defines a first section length L2.
  • the first section 302 corresponds to a portion of the sheath 308 distal to the second cut location 318
  • the second section 304 corresponds to a portion of the sheath 308 between the first cut location 317 and the second cut location 318
  • the third section 306 corresponds to a portion of the sheath 308 proximal to the first cut location 317.
  • cutting the sheath 308 at the first cut location 317 and/or the second cut location 318 includes cutting the sheath 308 at first and second cut angles, respectively, relative to the longitudinal axis X of the sheath 308.
  • FIG. 29A shows the sheath 308 cut at 90° angles relative to the longitudinal axis X of the sheath 308.
  • the sheath 308 can be cut at various first and second cut angles relative to the longitudinal axis X of the sheath so long as the third proximal end 314” of the first section 302 and the second distal end 310’ of the third section 306 remain couplable to the hub coupler 360.
  • the sheath 308 can be cut at first and/or second cut angles of 90° to 135° relative to the longitudinal axis X. In some examples, the sheath 308 can be cut at first and/or second cut angles of 90° to 105° relative to the longitudinal axis X. In some examples, the sheath 308 can be cut at first and/or second cut angles of 90° to 95° relative to the longitudinal axis X.
  • cutting the sheath 308 at first and/or second cut angles at or near 90° facilitates easier coupling with the hub coupler 360.
  • the first section length L2 is based on a length of the sheath 308 to be inserted into the patient’s vasculature Lmsertion, which is defined by the distance between the incision site and the treatment site. This is to ensure that position of the second cut location 318 along the sheath 308 yields a first section 302 having a first section length L2 that is at least the required insertion length Lmsertion. Accordingly, the axial position of the second cut location 318 can be selected anywhere along the sheath 308 such that a combined length of the first section length L2 and the third section length L4 is equal to or greater than the insertion length Lmsertion.
  • the combined length of the first section length L2 and the third section length L4 can optionally be approximately the same as insertion length Lmsertion so as to reduce the portion of the sheath 308 extending outside of the patient’s body during the procedure.
  • the desired insertion length Linsertion and corresponding combined first section length L2 and third section length L4 can vary depending on patient size and anatomy, as well as physician preferences.
  • additional cuts can be made to the sheath 308 so as to obtain the desired first section length L2 and/or third section length L4. Once the first section 302 and/or third section 306 has been cut to a desired first section length L2 and/or third section length L4, the second section 304 can be discarded.
  • the hub coupler 360 can be used to couple the first section 302 to the sheath hub 340.
  • the proximal end 364 of the hub coupler 360 is coupled to the distal end 346 of sheath hub 340 and the initial hub cap 320.
  • coupling the proximal end 364 of the hub coupler 360 to the sheath hub 340 includes coupling the tab 372 into the gap 350 formed between the sheath hub 340 and the proximal end 324 of the initial hub cap 320 (as shown in cross section at FIG. 27).
  • a second hub cap 320’ is then coupled to the hub coupler 360. This includes passing the second hub cap 320’ over the sheath 308 and moving the second hub cap 320’ proximally along the sheath 308 toward the distal end 366 of the hub coupler 360 until the proximal end 324’ of the second hub cap 320’ engages with the distal end 366 of the hub coupler 360.
  • the radially inwardly extending threaded region 330’ of the second hub cap 320’ is threadingly engaged with the radially outwardly extending threaded region 374 of the hub coupler 360.
  • the third proximal end 314” of the sheath 308 is positioned between the distal end 326’ of the second hub cap 320’ and the distal end 366 of the hub coupler 360 such that coupling the second hub cap 320’ to the hub coupler 360 fixes the length-adjusted sheath 308 to the hub coupler 360 and to the sheath hub 340.
  • a coupler seal 390 can be disposed between the distal end 366 of the hub coupler 360 and the threaded region 330’ of the second hub cap 320’, thereby reducing the risk of fluid leaking between the coupling.
  • the third proximal end 314’ ’ of the first section 302 of the sheath 308 is coupled to the distal end 366 of the hub coupler 360.
  • the first section 302 is held to the hub coupler 360 via an interference fit by inserting the distal end 366 of the hub coupler 360 into the proximal end 314’ ’ of the first section 302.
  • the first section 302 of the sheath 308 can be held to the distal end 366 of the hub coupler 360 using a press fit, a weld, and/or an adhesive. It is contemplated that the first section 302 can be coupled to the hub coupler 360 either before or after the hub coupler 360 is coupled to the sheath hub 340.
  • the adapter 380 can be used to accommodate a reduction in the inner diameter of the first section 302.
  • the proximal end 384 of the adapter can be coupled to the distal end 366 of the hub coupler 360 and the distal end 386 of the adapter 380 can be coupled to the third proximal end 314” of the sheath 308.
  • the sheath 308 is configured to facilitate passage of the delivery apparatus 10/medical device 12 through an incision site and to a treatment site within a patient’s body.
  • the insertion length Lmsertion, and accordingly, the desired combined first section length L2 and third section length L4 are determined before any portion of the sheath 308 is inserted into the incision site. This allows one or both of the first cut and second cut of the sheath 308 to be performed away from the patient’s body.
  • the hub coupler 360 is coupled to the sheath hub 340 and the first section 302 of the sheath 308 is coupled to the hub coupler 360, as provided herein.
  • the sheath 308 can be inserted at least partially into a blood vessel at the incision site and advanced toward the treatment site.
  • the portion of the sheath 308 that serves as the substitute distal end may have rough edges and/or shed particulates of the sheath 308.
  • rough edges at the second distal end 310’ of the sheath 308 may make insertion of the sheath 308 into the incision site more challenging and, if successfully inserted into the patient’s blood vessel, may induce trauma along the walls of the blood vessels while passing therethrough.
  • FIGS. 30-32 refer to an example introducer sheath system 500 including a sheath 308, an introducer locking hub 450, and an introducer 420 coupled to the introducer locking hub 450 and received within the sheath 308.
  • a portion of the introducer 420 is configured to enclose a distal end (for example, the second distal end 310’) of the sheath 308.
  • the introducer 420 reduces the risk that rough edges and/or particulates of the sheath 308 interfere with insertion of the sheath 308 into a patient’s blood vessels or cause trauma to the walls thereof while passing therethrough.
  • example sheath 308 illustrated in FIGS. 30 and 32 can have any of the attributes of the example sheath 308 provided above with respect to FIGS. 25-29B.
  • the sheath 308 has an initial sheath length LI, which corresponds to the distance between the initial distal end 310 and the initial proximal end 314 of the sheath 308.
  • some examples of the introducer sheath system 500 further include a sheath hub 340. It is contemplated that the sheath hub 340 illustrated in FIGS. 30 and 32 can have any of the attributes of the sheath hub 340 provided above with respect to FIGS. 25-29B.
  • the introducer locking hub 450 a proximal end 454 and a distal end 456 and defines a central lumen 458 extending longitudinally between the proximal end 454 and the distal end 456.
  • the distal end 456 of the introducer locking hub 450 includes means of engaging the proximal end 344 of the sheath hub 340, thereby coupling the introducer locking hub 450 to the sheath 308 such that an axial position of the introducer locking hub 450 relative to the sheath hub 340 is fixed.
  • FIGS. 30-32 show an example introducer 420 coupled to the introducer locking hub 450.
  • the introducer 420 is segmented into a proximal piece 424 and a separate distal piece 426 spaced axially from the proximal piece 424 along the longitudinal axis X.
  • the proximal piece 424 includes a proximal end 440 and a distal end 442
  • the distal piece 426 includes a proximal end 430 and a distal end 432.
  • FIG. 31 shows a cross-sectional view of the introducer 420.
  • the distal piece 426 has a tapered region 434 having an inner surface that widens toward a proximal end 430 of the distal piece 426.
  • the tapered region 434 refers to a surface of the proximal end 430 that tapers radially inward toward the distal end 432 of the distal piece 426.
  • FIG. 31 also shows that the proximal piece 424 has a tapered region 444 having an outer surface that is complementary to the inner surface of the tapered region 434 of the distal piece 426.
  • the outer surface of the tapered region 444 narrows toward the distal end 442 of the proximal piece 424.
  • the tapered region 444 refers to a surface that tapers radially inward toward the distal end 442.
  • the introducer 420 defines a central lumen 428 extending longitudinally therethrough.
  • the central lumen 428 is divided between the proximal piece 424 and the distal piece 426.
  • the proximal piece 424 defines a central lumen 476 corresponding to the portion of the central lumen 428 extending therethrough
  • the distal piece 426 defines a central lumen 474 corresponding to the portion of the central lumen 428 extending therethrough.
  • the example introducer 420 further comprises an optional hypotube 470 disposed within the central lumen 428 (for example, within the central lumen 474 and central lumen 428) of the introducer 420.
  • the hypotube 470 has a proximal end 472 and a distal end 475 and defines a central lumen 476 extending longitudinally between the proximal end 472 and the distal end 475.
  • the distal end 475 of the hypotube 470 is coupled to the distal piece 426 of the introducer 420 and is slidably disposed within the central lumen 474 of the proximal piece 424 such that axial movement of the hypo tube 470 within the central lumen 476 of the proximal piece 424 causes the distal piece 426 to move axially relative to the proximal piece 424.
  • This coupling can be formed by at least one of a press fit, an interference fit, a snap fit, a mechanical fastener, a chemical fastener (for example, an adhesive), a weld, a thermal process, and/or any other suitable coupling process known in the art, so long axial movement of the hypotube 470 causes corresponding axial movement of the distal piece 426.
  • advancement of the hypotube 470 axially in a distal direction causes the distal piece 426 to move from a first position to a second position distal to the first position, and axial movement of the hypotube 470 in a proximal direction causes the distal piece 426 to move from the second position to the first position.
  • FIG. 32 is a side view of the introducer sheath system of FIG. 30, where the introducer 420 is inserted into a length-adjusted sheath 308 (via a sheath hub 340).
  • the introducer 420 extends beyond the distal end 310’.
  • the introducer locking hub 450 is coupled to the sheath 308, the introducer 420 is received within the central lumen 312 of the sheath 308 such that the central lumen 428 of the introducer 420 is aligned with the central lumen 312 of the sheath 308, the central lumen 348 of the sheath hub 340, and the central lumen 458 of the introducer locking hub 450.
  • FIGS. 30-32 provide a method for setting the length of the sheath 308 in the introducer sheath system 300.
  • the method includes cutting the sheath 308 at a cut location 319 that is between the initial distal end 310 and the initial proximal end 314.
  • cutting the sheath 308 at cut location 319 divides the sheath 308 into a first section 302 and a second section 304.
  • the first section 302 corresponds to a portion of the sheath 308 distal to the cut location 319 and the second section 304 corresponds to a portion of the sheath 308 proximal to the cut location 319.
  • the first section 302 extends between the initial distal end 310 and a second proximal end 314’ formed directly distal of the cut location 319.
  • a distance between the initial distal end 310 and a second proximal end 314’ defines a first section length L2 of the first section 302.
  • the second section 304 extends between a second distal end 310’ formed directly proximate of the cut location 319 and the initial proximal end 314.
  • a distance between the second distal end 310’ and the initial proximal end 314 defines a second section length L3 of the second section 304.
  • the first section 302 can be discarded.
  • the method involves adjusting the length of the sheath 308 such that the second section length L3 corresponds to a desired sheath length.
  • the second section length L3 is based on a length of the sheath 308 to be inserted into the patient’s vasculature Linsertion, which is defined by the distance between the incision site and the treatment site. This is to ensure that the position of the cut location 319 along the sheath 308 yields a second section 304 having a second section length L3 that is at least the required insertion length Linsertion.
  • the axial position of the cut location 319 can be selected anywhere along the sheath 308 such that the second section length L3 is equal to or greater than the insertion length Linsertion-
  • the second section length L3 can optionally be approximately the same as insertion length Linsertion so as to reduce the portion of the sheath 308 extending outside of the patient’s body during the procedure.
  • the desired insertion length Linsertion and corresponding second section length L3 can vary depending on patient size and anatomy, as well as physician preferences.
  • the introducer 420 can be inserted into the sheath 308 and the introducer locking hub 450 can be coupled to the sheath hub 340 (and therefore to the second section 304 of the sheath 308).
  • the introducer locking hub 450 can be coupled to the sheath hub 340 (and therefore to the second section 304 of the sheath 308).
  • the method includes providing the second distal end 310’ of the second section 304 of the sheath 308 between the proximal piece 424 of the introducer 420 and the distal piece 426 of the introducer, thereby enclosing the second distal end 310’ between the two pieces and preventing the second distal end 310’ from extending radially outward beyond the outer diameter GDI of the distal piece 426.
  • this method of setting the length of the sheath 308 facilitates reducing the length of the sheath 308 while preventing any rough edges or particulates at the second distal end 310’ of the sheath 308 from interfering with insertion of the sheath 308 into the blood vessel of a patient or causing trauma along the walls thereof.
  • providing the second distal end 310’ between the proximal piece 424 of the introducer 420 and the distal piece 426 of the introducer 420 is achieved by axially moving the distal piece 426 relative to the first piece.
  • the distal piece 426 can be moved from the first position adjacent the proximal piece 424 to a second position axially spaced from the proximal piece 424 in a distal direction.
  • the method can also include positioning the second distal end 310’ within the tapered region 434 of the distal piece 426. When the distal piece 426 is moved distally into the second position, this can include positioning the second distal end 310’ longitudinally between the distal piece 426 and the proximal piece 424.
  • the method can further include moving the distal piece 426 proximally from the second position to the first position adjacent the proximal piece 424.
  • the second distal end 310’ can be enclosed between the proximal piece 424 of the introducer 420 and the distal piece 426 of the introducer 420 such that the distal end 310’ is held longitudinally therebetween and does not extend radially beyond the outer diameter ODI of the distal piece 426.
  • enclosing the second distal end 310’ of the sheath 308 within the tapered region 434 of the distal piece 426 of the introducer 420 can further include withdrawing the hypotube 470 from the central lumen 476 of the proximal piece 424 such that the distal piece 426 of the introducer abuts the proximal end 440 of the introducer 420.
  • cutting the sheath 308 includes cutting the sheath 308 at a cut angle relative to the longitudinal axis X of the sheath 308. Specifically, FIG. 30 shows the sheath 308 cut a 90° angle relative to the longitudinal axis X of the sheath 308.
  • the sheath 308 can be cut at various angles relative to the longitudinal axis X of the sheath so long as the second distal end 310’ of the second section 304 of the sheath 308 can be enclosed within tapered region 434 of introducer 420.
  • the sheath 308 can be cut at an angle of 90° to 135° relative to the longitudinal axis X.
  • the sheath 308 can be cut at an angle of 90° to 105° relative to the longitudinal axis X.
  • the sheath 308 can be cut at an angle of 90° to 95° relative to the longitudinal axis X.
  • cutting the sheath 308 at an angle at or near 90° facilitates easier coupling with the proximal piece 424 and the distal piece 426 of the introducer 420.
  • cutting the sheath 308 at an angle at or near 90° allows the second distal end 310’ to be evenly received within the tapered region 434 of the distal piece 426 of the introducer 420.
  • the sheath 308 is configured to facilitate passage of the delivery apparatus 10/medical device 12 through an incision site and to a treatment site within a patient’s body.
  • the insertion length Linsertion and accordingly, the desired second section length L3 (as determined by the cut location 319) is determined before any portion of the sheath 308 is inserted into the incision site. This allows the sheath 308 to be cut away from the patient’s body.
  • the coupled introducer 420 and sheath 308 can be inserted at least partially into a blood vessel at the incision site and advanced toward the treatment site. Moving the coupled introducer 420 and sheath 308 into the patient’s blood vessels causes the blood vessels to expand as a result of a radially outwardly directed force provided by the introducer 420.
  • the introducer 420 can then be uncoupled from the sheath 308 and withdrawn from the patient’s blood vessel. This can include slight advancement of the hypotube 470 axially in a distal direction to cause the distal piece 426 to move from the first position to the second position such that the second distal end 310’ can be released from between the proximal piece 424 and the distal piece 426.
  • moving the distal piece 426 to move from the first position to the second position can include advancing the distal piece 426 of the introducer 420 beyond the second distal end 310’ of the sheath 308.
  • the proximal piece 424 can be retained within the central lumen 312 of the sheath 308 such that the distal piece 426 is axially spaced apart from the proximal piece 424. [00229] With the sheath 308 uncoupled from the introducer 420, the introducer 420 can then be withdrawn from the sheath 308.
  • a medical device 12 such as a prosthetic heart valve
  • a delivery apparatus 10 can be advanced through the central lumen 312 toward the treatment site, for example, by coupling the medical device 12 to a delivery apparatus 10 and pushing the delivery apparatus through the central lumen 312.
  • FIGS. 33-38 refer to an example introducer sheath system 600 including a sheath 308, a sheath hub 340 disposed proximal to the sheath 308, a loader assembly 570 inserted into a proximal end 344 of the sheath hub 340, and a suture hub 550 at least partially surrounding the sheath 308.
  • the suture hub 550 is configured to couple the sheath 308 to the patient and resist axial movement of the sheath 308 relative to the patient, thereby setting the effective sheath length L e ff of the sheath 308 that is available to insert into the patient.
  • the loader assembly 570 extends through a central lumen 312 of the sheath 308, thereby providing rigidity and reducing the risk of kinking or poor usability of the sheath 308.
  • the example sheath 308 illustrated in FIG. 33 can have any of the attributes of the example sheath 308 provided above with respect to FIGS. 25-29B and 30-32. Accordingly, the sheath 308 extends distally from the sheath hub 340 has a sheath length Li, which corresponds to the distance between a distal end 310 and a proximal end 314 of the sheath 308. The sheath 308 defines a central lumen 312 extending longitudinally therethrough. Similarly, it is contemplated that the sheath hub 340 illustrated in FIG. 33 can have any of the attributes of the sheath hub 340 provided above with respect to FIGS. 25-29B and 30-32.
  • the introducer sheath system 600 includes a suture hub 550.
  • the suture hub 550 has a suture hub body 552 that includes a proximal surface 554 and a distal surface 556 opposite the proximal surface 554 and defines a central lumen 558 extending longitudinally therethrough.
  • the suture hub 550 defines one or more openings 560 extending through the suture hub body 552 between the proximal surface 554 and the distal surface 556.
  • the one or more openings 560 facilitate securing the suture hub 550 to the tissue (for example, the skin) of a patient.
  • the one or more openings 560 are sized and configured to house a suture thread.
  • a suture thread can be inserted into the one or more openings 560 and also into the skin of the patient, thereby coupling the suture hub 550 to the patient.
  • the distal surface 556 of the suture hub 550 can thus be axially fixed against the skin of a patient.
  • the suture hub 550 defines four openings 560 spaced evenly and circumferentially about the central lumen 558.
  • the suture hub 550 can define any number of suture openings 560, so long as the openings 560 facilitate coupling the suture hub 550 to the patient’s skin so as to resist axial movement.
  • the suture hub 550 receives the sheath 308 within the central lumen 558.
  • the suture hub 550 extends all the way around a circumference of the sheath 308.
  • this configuration ensures that the suture hub 550 cannot inadvertently become decoupled from the sheath 308.
  • the suture hub 550 may extend around only a portion of the circumference of the sheath 308.
  • the suture hub body 552 of the suture hub 550 may extend between two spaced apart ends so as to define a gap in the suture hub body 552 that is sized and configured to receive the sheath 308.
  • the suture hub body 552 may be openable so that the suture hub 550 is movable between an open configuration, in which a gap is defined within the suture hub body 552, and a closed configuration, in which the suture hub body 552 forms a closed loop.
  • Examples of the suture hub 550 that define a gap or are openable enable placement of the 550 around the sheath 308 after the sheath 308 has been inserted into an incision.
  • the suture hub 550 is movable between a slidable configuration and a coupled configuration.
  • the sheath 308 is axially slidable within the central lumen 558 of the suture hub 550.
  • this facilitates adjusting the axial position of the suture hub 550 along the length Li of the sheath 308.
  • the suture hub 550 prevents the sheath 308 from moving in an axially distal direction relative to the suture hub 550.
  • the suture hub 550 can be sized to form a press-fit with the suture hub 550 such that the sheath 308 resists axial movement relative to the suture hub 550.
  • the suture hub 550 includes a locking mechanism 562 that is fixedly coupled with the sheath 308 to resist axial movement of the sheath 308.
  • the locking mechanism 562 in the illustrated example includes internal threading extending along the central lumen 558 that engages complimentary threading extending along an external surface of the sheath 308.
  • FIG. 34 shows an enlarged view of the suture hub 550, including circumferentially-spaced openings 560 and a threaded locking mechanism 562.
  • a threaded locking mechanism 562 provides the added advantage of preventing sheath 308 from moving in an axially proximal direction relative to the suture hub 550 without rotation of the sheath 308 relative to the suture hub 550.
  • FIG. 35 shows an example suture hub 550 where the central lumen 558 narrows to form a press-fit configuration with the sheath 308 that extends therethrough.
  • the central lumen 558 can be tapered to match a corresponding taper of the sheath 308. This configuration facilitates adjustment of the axial position of the sheath 308 relative to the suture hub 550 without rotating the suture hub 550 or sheath 308.
  • the position of the suture hub 550 along the length Li of the sheath 308 determines the length of the sheath 308 that is available for insertion into a patient.
  • the distance between the distal surface 556 of the suture hub 550 and the initial distal end 310 of the sheath 308 defines an effective sheath length L e ff.
  • the effective sheath length L e ff corresponds to the length of the sheath that is received within the patient.
  • FIG. 33 shows that the example introducer sheath system 600 includes a loader assembly 570 that is inserted into the sheath hub 340 and sheath 308 to provide rigidity along the length of the sheath 308.
  • FIG. 36 illustrates an example loader assembly 570, which includes a base 572, a rigid tube 574 extending distally from the base 572 and defines a loader lumen 576 extending longitudinally through the base 572 and the rigid tube 574.
  • the loader assembly 570 includes a loader cap 578 that is positioned at a proximal end of the base 572 and extends the loader lumen 576.
  • the loader cap 578 includes an opening 580 that is configured to receive a delivery apparatus 10 for implanting a medical device 12.
  • the example delivery apparatus 10 illustrated in FIG. 33 can have any of the attributes of the delivery apparatus 10 provided above with respect to FIGS. 1-3 and can be used for loading a balloon catheter and prosthetic valve into the introducer sheath system 600.
  • the delivery apparatus 10 is coupled to the loader assembly 570 by inserting the delivery apparatus 10 into the opening 580 of the loader cap 578 and advancing the delivery apparatus through the loader lumen 576.
  • the base 572 and or rigid tube 574 can protect delicate parts of delivery apparatus 10/medical device 12 from the internal components and seals of the sheath hub 340.
  • the loader assembly 570 is couplable with the sheath hub 340.
  • the loader cap 578 is couplable to the proximal end 344 of the sheath hub 340.
  • the rigid tube 574 extends to a location within the sheath 308 that corresponds to the axial location of the suture hub 550 when the sheath 308 is in the coupled configuration.
  • the rigid tube 574 can extend to a location within the sheath 308 that corresponds to the axial location of the distal surface 556 of the suture hub 550 when the sheath 308 is in the coupled configuration.
  • the rigid tube 574 is able to provide rigidity to the introducer sheath system 600 at the incision site and along the length of the sheath 308 that extends outside of the patient’s body. This rigidity reduces the risk of kinking in the sheath 308 and improves stability of the excess length of sheath 308. Accordingly, use of the loader assembly 570 allows for easier handling of a sheath 308 that has a sheath length Li that is longer than the effective sheath length L e ff needed to reach a treatment site within a patient.
  • the sheath 308 of the introducer sheath system 600 is configured to facilitate passage of the delivery apparatus 10/medical device 12 through an incision site and toward a treatment site within a patient’s body.
  • the incision site corresponds to an access cite to a vascular system of the patient, such as the femoral access site SF, the carotid access site Sc, the axillary access site SA, and/or the subclavian access site Ss shown in FIG. 24.
  • the sheath 308 has an effective sheath length L e ff that is defined as the length of the sheath 308 that extends between the distal surface 556 of the suture hub 550 and distal end 310 of the sheath 308. Accordingly, the effective sheath length L e ff corresponds to the length of the sheath 308 that is received within the patient. [00245] In some examples, it is contemplated that the effective sheath length Left is determined before any portion of the sheath 308 is inserted into the incision site. This allows for positioning/coupling of the suture hub 550 to the sheath 308 to be performed away from the patient’s body.
  • the suture hub 550 is axially positioned along the sheath 308 by sliding the suture hub 550 along an outer surface of the 308 so that the sheath 308 extends through a central lumen 558 of the suture hub 550. Once positioned at the desired axial location, the suture hub 550 is fixedly coupled to the sheath 308 to resist axial movement of the sheath 308 relative to the suture hub 550. Once the suture hub 550 is coupled to the sheath 308, the sheath 308 can be inserted at least partially into a blood vessel at the incision site and advanced toward the treatment site until a distal surface 556 of the suture hub 550 abuts the surface of the patient’s skin adjacent to the incision site.
  • the suture hub 550 can then be coupled to the surface of the patient’s skin by fixing the suture hub 550 to the patient’s skin using sutures extending through one or more openings 560 defined by the suture hub 550. With the suture hub 550 coupled to the sheath 308, temporarily suturing the suture hub 550 to the patient’s skin has the effect of setting the effective sheath length L e ff that extends into the patient’s vasculature.
  • coupling the suture hub 550 to the sheath 308 can comprise engaging an internal threading defined within the central lumen 558 of the suture hub 550 with a threaded external surface of the sheath 308.
  • coupling the suture hub 550 to the sheath 308 can comprise engaging a narrowed portion of the central lumen 558 of the suture hub 550 to form a press-fit configuration with the sheath 308.
  • the suture hub 550 can be fixedly coupled to the sheath 308 after the sheath 308 is at least partially inserted into a blood vessel at the incision site. This approach may be useful in instances when determining the effective sheath length L e ff is difficult. Under this approach, the suture hub 550 is slid along the outer surface of the sheath 308 until it abuts the surface of the patient’s skin adjacent the incision site. The suture hub 550 can then be fixedly coupled to the surface of the patient’s skin and fixedly coupled to the sheath 308 such that the suture hub 550 resists axial movement of the sheath 308.
  • the suture hub 550 is coupled to the surface of the patient’s skin by fixing the suture hub 550 to the patient’s skin using sutures extending through one or more openings 560 defined by the suture hub 550.
  • a medical device 12 can be pushed through a central lumen 312 of the sheath 308 toward the treatment site.
  • the introducer sheath system 600 can further comprise a loader assembly 570 that is inserted into a central lumen 348 of the sheath hub 340 and into the central lumen 312 of the sheath 308.
  • the loader assembly 570 includes a base 572, a rigid tube 574 extending distally from the base 572 and defines a loader lumen 576 extending longitudinally through the base 572 and the rigid tube 574. Inserting the loader assembly 570 into the sheath hub 340 includes aligning the loader lumen 576 with the central lumen 348 of the sheath hub 340 and the central lumen 312 of the sheath 308.
  • the loader assembly 570 includes a loader cap 578 that is positioned at a proximal end of the base 572 and extends the loader lumen 576.
  • the loader assembly 570 can be pushed through the central lumen 348 of the sheath hub 340 and the central lumen 312 of the sheath 308 until the rigid tube 574 extends to a location within the sheath 308 that corresponds to the axial location of the suture hub 550 when the suture hub 550 is coupled to the sheath 308.
  • the loader assembly 570 With the loader assembly 570 inserted into the sheath hub 340 and sheath 308 and the rigid tube 574 advanced to a desired position therein, the loader assembly 570 can be coupled to the sheath hub 340.
  • the loader cap 578 can be coupled to the proximal end 344 of the sheath hub 340.
  • the loader cap 578 can be threadingly coupled to the proximal end 344 of the sheath hub 340.
  • placement of the rigid tube 574 within the sheath 308 provides rigidity to the portion of the sheath 308 that is external to the patient.
  • rigid tube 574 provides rigidity to the portion of the sheath 308 that extends between a proximal end 314 of the sheath 308 and the proximal surface 554 of the suture hub 550, which abuts the surface of the patient’s skin.
  • the medical device 12 is inserted into the loader lumen 576 through an opening 580 defined in the loader cap 578. Pushing the medical device 12 through the central lumen 312 of the sheath 308 toward the treatment site can thus also include pushing the medical device 12 through the loader lumen 576 of the loader assembly 570.
  • Example 1 A method of setting a sheath length, the method comprising: handling a sheath, the sheath extending an initial sheath length between an initial distal end and an initial proximal end and defining a central lumen extending longitudinally therethrough, the initial proximal end of the sheath coupled to an initial sheath hub; cutting the sheath at a cut location between the initial distal end and the initial proximal end so as to form a second proximal end and a second distal end on either side of the cut location; wherein cutting the sheath divides the sheath into a first section that has a first section length extending from the initial distal end to the second proximal end and a second section that extends from the second distal end to the initial proximal end; and coupling the second proximal end of the first section with a second sheath hub.
  • Example 2 The method according to any example herein, particularly example 1, further comprising determining an insertion length corresponding to a length of the sheath that is received within the patient's vasculature, wherein the insertion length extends from an incision site to a treatment site.
  • Example 3 The method according to any example herein, particularly examples 1-2, further comprising selecting the cut location such that the first section length is equal to or greater than the insertion length.
  • Example 4 The method according to any example herein, particularly example 3, wherein the cut location is selected such that the first section length is approximately the insertion length.
  • Example 5 The method according to any example herein, particularly examples 1-4, wherein cutting the sheath comprises cutting the sheath at a cut angle relative to a longitudinal axis of the sheath.
  • Example 6 The method according to any example herein, particularly example 5, wherein cutting the sheath comprises cutting the sheath at a 90° angle relative to the longitudinal axis of the sheath.
  • Example 7 A method of delivering a medical device through a sheath, the method comprising: handling a radially expandable sheath including a continuous inner layer extending an initial sheath length between an initial distal end and an initial proximal end and defining a central lumen extending longitudinally therethrough, the initial proximal end of the sheath coupled to an initial sheath hub and the inner layer having at least one folded portion extending along a length of the inner layer; cutting the sheath at a cut location between the initial distal end and the initial proximal end so as to form a second proximal end and a second distal end on either side of the cut location, wherein the sheath is divided into a first section that extends from the initial distal end to the second proximal end and a second section that extends from the second distal end to the initial proximal end; coupling the second proximal end of the first section with a second sheath hub; inserting the shea
  • Example 8 The method according to any example herein, particularly example 7, further comprising: advancing a dilator into the central lumen of the sheath through the second sheath hub; inserting the sheath and coupled dilator at least partially into a blood vessel of a patient at an insertion site; advancing the dilator within the central lumen of the sheath until the dilator is positioned at a treatment site within the patient’s blood vessel, thereby moving the sheath from an unexpanded configuration to an expanded configuration and expanding the patient's blood vessel; and withdrawing the dilator from the central lumen of the sheath.
  • Example 9 The method according to any example herein, particularly examples 7-8, wherein the inner layer includes at least one folded portion, wherein locally expanding the central lumen of the sheath causes a length of the folded portion to at least partially unfold.
  • Example 10 The method according to any example herein, particularly examples 7- 9, wherein the medical device is a prosthetic device mounted in a radially crimped state on a delivery apparatus.
  • Example 11 The method according to any example herein, particularly example 10, wherein the prosthetic device comprises a prosthetic heart valve and the method further comprises implanting the prosthetic heart valve at a treatment site within the patient.
  • Example 12 The method according to any example herein, particularly example 11, wherein the prosthetic heart valve is mounted on a balloon catheter of a delivery apparatus as the prosthetic heart valve is advanced through the sheath.
  • Example 13 A sheath coupling system comprising: a sheath hub comprising a hub body having a proximal end and a distal end and defining a lumen extending longitudinally therethrough, an initial hub cap coupled to the distal end of the sheath hub, the initial hub cap having an initial hub cap proximal end and an initial hub cap distal end and defining an initial hub cap lumen extending longitudinally therethrough; and a hub coupler coupled to the initial hub cap, the hub coupler comprising a hub coupler body having a hub coupler proximal end and a hub coupler distal end and defining a hub coupler lumen extending longitudinally therethrough, a secondary hub cap disposed distal to the initial hub cap and coupled to the hub coupler, the secondary hub cap having a secondary hub cap proximal end and a secondary hub cap distal end and defining a secondary hub cap lumen extending longitudinally therethrough; a sheath comprising a distal end and a proximal end and
  • Example 14 The sheath coupling system according to any example herein, particularly example 13, wherein the proximal end of the hub coupler has a radially expanded diameter relative to the distal end of the hub coupler, wherein the proximal end receives the initial hub cap and the distal end is received within the secondary hub cap.
  • Example 15 The sheath coupling system according to any example herein, particularly examples 13-14, wherein an inner surface of the hub coupler body has a profile that complements an outer surface of the initial hub cap.
  • Example 16 The sheath coupling system according to any example herein, particularly examples 13-15, wherein the proximal end of hub coupler further comprises a tab extending radially inward from the hub coupler body, wherein the tab is configured to couple with a gap formed between the sheath hub and the proximal end of the initial hub cap.
  • Example 17 The sheath coupling system according to any example herein, particularly examples 13-16, wherein the hub coupler further comprises a radially outwardly extending threaded region disposed adjacent the distal end, wherein the threaded region is configured to engage a radially inwardly extending threaded region defined at the proximal end of the secondary hub cap.
  • Example 18 The sheath coupling system according to any example herein, particularly examples 13-17, wherein the system further comprises an adapter, the adapter comprising an adapter body having a proximal end and a distal end and defining a lumen extending longitudinally therethrough, wherein the adapter tapers from a first adapter diameter at the proximal end to a second adapter diameter at the distal end.
  • Example 19 The sheath coupling system according to any example herein, particularly example 18, wherein the first adapter diameter is sized and configured to receive the distal end of the hub coupler, and the second adapter diameter is sized and configured to be received within a proximal end of the sheath.
  • Example 20 The sheath coupling system according to any example herein, particularly examples 13-19, wherein the system further comprises a coupler seal disposed between the distal end of the hub coupler and the threaded region of the secondary hub cap.
  • Example 21 A method of setting a sheath length, the method comprising: handling a sheath, the sheath extending an initial sheath length between an initial distal end and an initial proximal end and defining a central lumen extending longitudinally therethrough, the initial proximal end of the sheath coupled to an initial sheath hub cap, and the initial sheath hub cap coupled to a sheath hub; cutting the sheath at a first cut location between the initial distal end and the initial proximal end so as to form a second distal end and a second proximal end on either side of the cut location; cutting the sheath at a second cut location between the first cut location and the initial distal end so as to form a third dis
  • Example 22 The method according to any example herein, particularly example 21, wherein the first cut location is adjacent the distal end of the initial sheath hub cap.
  • Example 23 The method according to any example herein, particularly examples 21-22, further comprising determining an insertion length corresponding to a length of the sheath that is received within the patient's vasculature, wherein the insertion length extends from an incision site to a treatment site.
  • Example 24 The method according to any example herein, particularly examples 21-23, further comprising selecting the first cut location and second cut location such that a combined length of the first section length and third section length is equal to or greater than the insertion length.
  • Example 25 The method according to any example herein, particularly example 24, wherein the first cut location and second cut location are selected such that combined length of the first section length and third section length is approximately the insertion length.
  • Example 26 The method according to any example herein, particularly examples 21-25, wherein cutting the sheath at a first cut location comprises cutting the sheath at a first cut angle relative to a longitudinal axis of the sheath.
  • Example 27 The method according to any example herein, particularly example 26, wherein cutting the sheath at a first cut location comprises cutting the sheath at a 90° angle relative to the longitudinal axis of the sheath.
  • Example 28 The method according to any example herein, particularly examples 21-27, wherein cutting the sheath at a second cut location comprises cutting the sheath at a second cut angle relative to a longitudinal axis of the sheath.
  • Example 29 The method according to any example herein, particularly example 28, wherein cutting the sheath at a second cut location comprises cutting the sheath at a 90° angle relative to the longitudinal axis of the sheath.
  • Example 30 The method according to any example herein, particularly examples 21-29, wherein coupling the proximal end of a hub coupler to the distal end of the sheath hub further comprises coupling a tab extending radially inward from the hub coupler body with a gap formed between the sheath hub and the proximal end of the initial hub cap.
  • Example 31 The method according to any example herein, particularly examples 21-30, wherein coupling the proximal end of the secondary hub cap to the distal end of the hub coupler further comprises providing and/or positioning a coupler seal between the distal end of the hub coupler and the threaded region of the secondary hub cap.
  • Example 32 The method according to any example herein, particularly examples 21-31, further comprising inserting the distal end of the hub coupler into the third proximal end of the first section of the sheath.
  • Example 33 The method according to any example herein, particularly examples 21-32, further comprising coupling the proximal end of an adapter to the distal end of hub coupler, wherein the adapter tapers from a first adapter diameter at the proximal end to a second adapter diameter at a distal end.
  • Example 34 The method according to any example herein, particularly example 33, further comprising inserting distal end of the adapter into the third proximal end" of the sheath.
  • Example 35 A method of delivering a medical device, the method comprising handling a radially expandable sheath including a continuous inner layer extending an initial sheath length between an initial distal end and an initial proximal end and defining a central lumen extending longitudinally therethrough, the initial proximal end of the sheath coupled to an initial sheath hub cap, the initial sheath hub cap coupled to a sheath hub, and the inner layer having at least one folded portion extending along a length of the inner layer; cutting the sheath at a first cut location between the initial distal end and the initial proximal end so as to form a second distal end and a second proximal end on either side of the cut location; cutting the sheath at a second cut location between the first cut location and the initial dis
  • Example 36 The method according to any example herein, particularly example 35, further comprising: advancing a dilator into the central lumen of the sheath through the sheath hub; inserting the sheath and coupled dilator at least partially into a blood vessel of a patient at an insertion site; advancing the dilator within the central lumen of the sheath until the dilator is positioned at a treatment site within the patient's blood vessel, thereby moving the sheath from an unexpanded configuration to an expanded configuration and expanding the patient’s blood vessel; and withdrawing the dilator from the central lumen of the sheath.
  • Example 37 The method according to any example herein, particularly examples 35-36, wherein the inner layer includes at least one folded portion, wherein locally expanding the central lumen of the sheath causes a length of the folded portion to at least partially unfold.
  • Example 38 The method according to any example herein, particularly examples 35-37, wherein the medical device is a prosthetic device mounted in a radially crimped state on a delivery apparatus.
  • Example 39 The method according to any example herein, particularly example 38, wherein the prosthetic device comprises a prosthetic heart valve and the method further comprises implanting the prosthetic heart valve at a treatment site within the patient.
  • Example 40 The method according to any example herein, particularly example 39, wherein the prosthetic heart valve is mounted on a balloon catheter of a delivery apparatus as the prosthetic heart valve is advanced through the sheath.
  • Example 41 An introducer sheath system comprising: a sheath extending a length between a distal end and a proximal end and defining a central lumen extending longitudinally therethrough; an introducer locking hub comprising a hub body having a proximal end and a distal end and defining a central lumen extending longitudinally between the proximal end and the distal end; and an introducer coupled to the introducer locking hub and received within the sheath, the introducer extending beyond the distal end of the hub body, the introducer comprising a proximal piece and a separate distal piece, the proximal piece coupled to the introducer locking hub and defining a central lumen extending therethrough, wherein the distal end of the sheath is provided between the proximal piece and the distal piece of the introducer such that the distal end of the sheath does not extend radially beyond an outer diameter of the distal piece of the introducer.
  • Example 42 The introducer system according to any example herein, particularly example 41, wherein the distal piece of the introducer is movable from a first position adjacent the proximal piece to a second position axially spaced from the proximal piece.
  • Example 43 The introducer system according to any example herein, particularly examples 41-42, wherein the distal piece comprises a tapered inner surface that widens toward a proximal end of the distal piece, wherein the distal end of the sheath is provided within the tapered inner surface.
  • Example 44 The introducer system according to any example herein, particularly example 43, wherein the proximal piece comprises a tapered outer surface that is complementary to the tapered inner surface of the distal piece.
  • Example 45 The introducer system according to any example herein, particularly example 44, wherein the distal end of the sheath is provided longitudinally between the tapered inner surface of the distal piece and the tapered outer surface of the proximal piece.
  • Example 46 The introducer system according to any example herein, particularly examples 41-45, further comprising a sheath hub with a central lumen extending therethrough, the sheath hub coupled to the proximal end of the sheath, the central lumen of the sheath hub aligned with the central lumens ,458 of the sheath and the introducer locking hub.
  • Example 47 The introducer system according to any example herein, particularly examples 41-46, further comprising a hypotube disposed within the central lumen of the introducer, the hypotube having a proximal end and a distal end and defining a central lumen extending longitudinally between the proximal end and the distal end.
  • Example 48 The introducer system according to any example herein, particularly example 47, wherein the distal end of the hypotube is coupled to the distal piece of the introducer and at least a portion of the hypotube is slidably disposed in the central lumen of the proximal piece of the introducer such that movement of the hypotube within the central lumen of the proximal piece causes the distal piece of the introducer to move with respect to the proximal piece of the introducer.
  • Example 49 The introducer system according to any example herein, particularly example 48, wherein axial movement of the hypotube within the central lumen of the proximal piece of the introducer causes a corresponding axial movement of the distal piece of the introducer, wherein, when the introducer is in the first position, axial movement of the hypotube in a distal direction causes the distal piece to move from the first position to the second position, wherein, when the introducer is in the second position, axial movement of the hypotube in a proximal direction causes the distal piece to move from the second position to the first position.
  • Example 50 A method of setting a sheath length, the method comprising: handling a sheath, the sheath extending an initial sheath length between an initial distal end and an initial proximal end and defining a central lumen extending longitudinally therethrough, the initial proximal end of the sheath coupled to a sheath hub; cutting the sheath at a cut location between the initial distal end and the initial proximal end so as to form a second proximal end and a second distal end on either side of the cut location, wherein cutting the sheath divides the sheath into a first section that has a first section length extending from the initial distal end to the second proximal end and a second section that has a second section length extending from the second distal end to the initial proximal end; inserting an introducer into the sheath hub and advancing the introducer through the central lumen of the sheath; moving a distal piece of the introducer from a first
  • Example 51 The method according to any example herein, particularly example 50, further comprising enclosing the initial distal end of the sheath between the tapered region of the distal piece and a complementary tapered region of the proximal piece.
  • Example 52 The method according to any example herein, particularly examples 50-51, wherein moving the distal piece of the introducer from the first position to the second position further comprises advancing a hypotube slidably disposed within a central lumen of the proximal piece and coupled to the distal piece axially in a distal direction.
  • Example 53 A method of delivering a medical device, the method comprising: handling a sheath, the sheath extending an initial sheath length between an initial distal end and an initial proximal end and defining a central lumen extending longitudinally therethrough, the initial proximal end of the sheath coupled to a sheath hub; cutting the sheath at a cut location between the initial distal end and the initial proximal end so as to form a second proximal end and a second distal end on either side of the cut location, wherein cutting the sheath divides the sheath into a first section that has a first section length extending from the initial distal end to the second proximal end and a second section that has a second section length extending from the second distal end to the initial proximal end; inserting an introducer into the sheath hub and advancing the introducer through the central lumen of the sheath; moving a distal piece of the introducer from a first
  • Example 54 The method according to any example herein, particularly example 53, further comprising coupling the introducer to an introducer locking hub, the introducer locking hub comprising a proximal end and a distal end and defining a central lumen extending longitudinally between the proximal end and the distal end, wherein the introducer extends distally from the introducer locking hub.
  • Example 55 The method according to any example herein, particularly example 54, further comprising coupling the distal end of the introducer locking hub to the proximal end sheath hub such that an axial position of the introducer locking hub relative to the sheath hub is fixed.
  • Example 56 The method according to any example herein, particularly examples 53-55, wherein moving the distal piece of the introducer from the first position to the second position further comprises advancing the distal piece of the introducer beyond the second distal end of the sheath.
  • Example 57 The method according to any example herein, particularly example 56, wherein advancing the distal piece of the introducer beyond the second distal end of the sheath further comprises retaining the proximal piece within the central lumen of the sheath such that the distal piece is axially spaced apart from the proximal piece.
  • Example 58 The method according to any example herein, particularly examples 53-57, wherein enclosing the initial distal end of the sheath within the tapered region of the distal piece of the introducer further comprises withdrawing the distal piece in a proximal direction toward the proximal piece, thereby holding the second distal end of the sheath longitudinally between the distal piece and the proximal piece.
  • Example 59 The method according to any example herein, particularly example 58, further comprising coupling a hypotube to the distal piece, the hypotube slidably disposed within the central lumen of the proximal piece.
  • Example 60 The method according to any example herein, particularly example 59, wherein moving the distal piece of the introducer from the first position to the second position further comprises pushing the hypotube distally within the central lumen of the proximal piece.
  • Example 61 The method according to any example herein, particularly examples 59-60, wherein enclosing the initial distal end of the sheath within the tapered region of the distal piece of the introducer further comprises withdrawing the hypotube from the central lumen of the proximal piece such that the distal piece of the introducer abuts the proximal piece of the introducer.
  • Example 62 An introducer sheath system comprising: a sheath hub comprising a proximal end and distal end and defining a lumen extending longitudinally therethrough; a sheath coupled to and extending distally from the sheath hub, the sheath extending a sheath length between a distal end and a proximal end and defining a central lumen extending longitudinally therethrough; and a suture hub at least partially surrounding the sheath, the suture hub having a suture hub body with a proximal surface and a distal surface and defining a central lumen extending longitudinally therethrough, the suture hub further comprising one or more openings sized to house a suture for securing the suture hub to a patient; wherein the sheath is movable between a slidable configuration, in which the sheath is axially slidable within the central lumen of the suture hub, and a coupled configuration, in which the sheath
  • Example 63 The introduce sheath system according to any example herein, particularly example 62, further comprising a loader assembly insertable within the sheath hub, the loader assembly comprising a base, a rigid tube extending distally from the base, and defining a loader lumen extending longitudinally through the base and the rigid tube, wherein when inserted into the sheath hub, the rigid tube extends to a location within the sheath corresponding to the axial location of the suture hub when the sheath is in the coupled configuration.
  • Example 64 The introduce sheath system according to any example herein, particularly examples 62-63, wherein the locking mechanism comprises internal threading that engages a threaded external surface of the sheath.
  • Example 65 The introduce sheath system according to any example herein, particularly examples 62-63, wherein the locking mechanism comprises a narrowing of central lumen to form a press-fit configuration with the sheath.
  • Example 66 The introduce sheath system according to any example herein, particularly examples 63-65, wherein the rigid tube extends to a location within the sheath corresponding to the axial location of the distal surface of the suture hub when the sheath is in the coupled configuration.
  • Example 67 The introduce sheath system according to any example herein, particularly example 66, wherein the loader assembly further comprises a loader cap that defines a lumen therethrough, the loader cap couplable to the proximal end of the sheath hub.
  • Example 68 A method of delivering a medical device through a sheath, the method comprising: inserting a sheath into a patient at an incision site; pushing a distal end of the sheath to a location within the patient's vasculature adjacent a treatment site; sliding a suture hub along an outer surface of the sheath; coupling the suture hub to a surface of the patient's skin adjacent to the incision site; fixedly coupling the suture hub and the sheath so as to resist axial movement of the sheath, wherein an effective sheath length is defined as the length of the sheath that extends between a distal surface of the suture hub and the distal end of the sheath and corresponds to a length of the sheath that is received within a patient; and pushing a medical device through the sheath toward the treatment site.
  • Example 69 The method according to any example herein, particularly example 68, further comprising inserting a loader assembly into a lumen of a sheath hub and into a central lumen of the sheath, the loader assembly comprising a base, a rigid tube extending distally from the base, and defining a loader lumen extending longitudinally through the base and the rigid tube, wherein the loader lumen is aligned with the lumen of the sheath hub and the central lumen of the sheath; and pushing the loader assembly into the lumen until the rigid tube extends to a location within the sheath corresponding to the axial location of the suture hub when the suture hub is coupled to the sheath, thereby providing rigidity to a portion of the sheath extending between the proximal end of the sheath and the proximal surface of the suture hub, which corresponds to a portion of the sheath that is external to the patient, wherein pushing the medical device through the sheath
  • Example 70 The method according to any example herein, particularly examples 68-69, wherein coupling the distal surface of the suture hub to a surface of a patient's skin at an incision site further comprises fixing the suture hub to the patient's skin using sutures extending through an opening defined by the suture hub.
  • Example 71 The method according to any example herein, particularly examples
  • the incision site corresponds to an access site to a vascular system of the patient.
  • Example 72 The method according to any example herein, particularly examples
  • Example 73 The method according to any example herein, particularly example 72, wherein coupling the loader assembly to the sheath hub further comprises coupling a loading cap to the proximal end of the sheath hub, the loading cap defining an opening therein.
  • Example 74 The method according to any example herein, particularly examples 72-73, further comprising inserting the medical device into the loader lumen through the opening.
  • Example 75 The method according to any example herein, particularly examples 68-74, wherein coupling the suture hub and the sheath further comprises engaging an internal threading defined within the central lumen of the suture hub with a threaded external surface of the sheath.
  • Example 76 The method according to any example herein, particularly examples 68-74, wherein coupling the suture hub and the sheath further comprises engaging a narrowed portion of the central lumen of the suture hub to form a press-fit configuration with the sheath.

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Abstract

L'invention concerne des systèmes et des procédés pour régler une longueur de gaine utilisée dans un système de gaine d'introduction pour déployer un dispositif médical. La capacité à régler la longueur de la gaine permet de réduire une partie de la gaine qui reste à l'extérieur du patient pendant des interventions médicales, une distance entre un site d'incision et un site de traitement étant inférieure à une longueur initiale de la gaine.
PCT/US2025/042149 2024-08-16 2025-08-15 Dispositifs et procédés de stabilisation de systèmes de gaine Pending WO2026039724A2 (fr)

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WO2026039724A2 true WO2026039724A2 (fr) 2026-02-19
WO2026039724A3 WO2026039724A3 (fr) 2026-03-26

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